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A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age

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ClinicalTrials.gov Identifier: NCT01079949
Recruitment Status : Terminated (Trial was terminated due to low recruitment rate)
First Posted : March 3, 2010
Results First Posted : February 20, 2013
Last Update Posted : February 27, 2014
Sponsor:
Collaborator:
Merck, S.L., Spain
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Infertility
Ovulation Induction
Interventions Drug: r-hLH + r-hFSH
Drug: r-hFSH
Drug: Recombinant Human Choriogonadotropin (r-hCG)
Drug: GnRH antagonist
Enrollment 93

Recruitment Details  
Pre-assignment Details  
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once. Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Period Title: Overall Study
Started 46 47
Completed 31 34
Not Completed 15 13
Reason Not Completed
Withdrawal before r-hCG administration             2             3
Withdrawal between rhCG-ovum pickup(OPU)             4             8
Withdrawal between OPU - embryo transfer             8             2
Randomized but not treated             1             0
Arm/Group Title r-hFSH + r-hLH r-hFSH Total
Hide Arm/Group Description Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once. Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once. Total of all reporting groups
Overall Number of Baseline Participants 45 47 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 47 participants 92 participants
36.6  (2.6) 36.3  (3.0) 36.4  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 92 participants
Female
45
 100.0%
47
 100.0%
92
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Oocytes Retrieved
Hide Description Number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.
Time Frame Ovum pick-up (OPU) day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. "N" (number of participants analyzed) signifies those participants who underwent ovum pick up.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 39 36
Mean (Standard Deviation)
Unit of Measure: oocytes
10  (3.8) 10  (5.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection r-hFSH + r-hLH, r-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5739
Comments [Not Specified]
Method Wilcoxon two sample test
Comments [Not Specified]
2.Primary Outcome
Title Number of Mature Oocytes Retrieved
Hide Description Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The nuclear maturity is assessed based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage or atretic.
Time Frame OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. "N" (number of participants analyzed) signifies those participants who underwent ovum pick up.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 39 36
Measure Type: Number
Unit of Measure: mature oocytes
Geminal vesicle (GV) 60 37
Meta-I 44 26
Meta-II 275 292
Atresic 10 4
3.Primary Outcome
Title Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)
Hide Description Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.
Time Frame S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who had received at least 1 dose of the study medication.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 45 47
Measure Type: Number
Unit of Measure: participants
0 0
4.Primary Outcome
Title Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)
Hide Description Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.
Time Frame S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who had received at least 1 dose of the study medication.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 45 47
Measure Type: Number
Unit of Measure: cycles
0 0
5.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Time Frame S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who had received at least 1 dose of the study medication.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 45 47
Measure Type: Number
Unit of Measure: participants
3 0
6.Secondary Outcome
Title Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day
Hide Description [Not Specified]
Time Frame r-hCG day (end of stimulation cycle [approximately 9 days])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 45 47
Mean (Standard Deviation)
Unit of Measure: follicles
8.6  (3.9) 7.4  (3.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection r-hFSH + r-hLH, r-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1734
Comments [Not Specified]
Method Wilcoxon two sample test
Comments [Not Specified]
7.Secondary Outcome
Title Endometrial Thickness on Recombinant Human Choriogonadotropin (r-hCG) Day
Hide Description Endometrial thickness measurement was performed on the day of r-hCG administration.
Time Frame r-hCG day (end of stimulation cycle [approximately 9 days])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 42 44
Mean (Standard Deviation)
Unit of Measure: mm
9.5  (2.1) 8.8  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection r-hFSH + r-hLH, r-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0642
Comments [Not Specified]
Method Wilcoxon two sample test
Comments [Not Specified]
8.Secondary Outcome
Title Number of Fertilized Oocytes (2 Pronuclei [PN])
Hide Description Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.
Time Frame OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. "N" (number of participants analyzed) signifies those participants who underwent ovum pick up.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 39 36
Measure Type: Number
Unit of Measure: 2PN oocytes
203 203
9.Secondary Outcome
Title Number of Fertilized Oocytes at Stage 2 Pronuclei (2PN) or Higher Than 2PN
Hide Description Oocytes were fertilized using ICSI technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN. Fertilized oocytes at stage higher then 2PN are those oocytes which consist more than 2 pronuclei like oocyte having 3 pronuclei termed as 3PN, oocyte having 4 pronuclei termed as 4PN.
Time Frame Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. "N" (number of participants analyzed) signifies those participants who underwent ovum pick up.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 39 36
Measure Type: Number
Unit of Measure: oocytes
210 210
10.Secondary Outcome
Title Number and Quality of Embryos
Hide Description Embryos were classified into 5 different grades (1 to 5) based on their capacity of implantation. Grade 1 embryos were those with best capacity of implantation and Grade 5 embryos were those with worst capacity of implantation.
Time Frame Day 2-3 post OPU (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. "N" (number of participants analyzed) signifies those participants who continued with follicular development.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 39 35
Measure Type: Number
Unit of Measure: embryos
1 22 39
2 46 35
3 56 49
4 18 13
5 64 70
11.Secondary Outcome
Title Implantation Rate
Hide Description Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.
Time Frame Day 35-42 post OPU (34-38 hours post r-hCG day {end of stimulation cycle [approximately 9 days]})
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 31 34
Mean (Standard Deviation)
Unit of Measure: percent sacs per embryo
30  (30) 20  (30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection r-hFSH + r-hLH, r-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4080
Comments [Not Specified]
Method Wilcoxon two sample test
Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants With Clinical Pregnancies
Hide Description Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.
Time Frame Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 45 47
Measure Type: Number
Unit of Measure: participants
14 12
13.Secondary Outcome
Title Number of Participants in Whom Recombinant Human Chorionic Gonadotropin (r-hCG) Was Not Administered Due to Poor Response
Hide Description Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment.
Time Frame r-hCG day (end of stimulation cycle [approximately 9 days])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 45 47
Measure Type: Number
Unit of Measure: participants
1 3
14.Secondary Outcome
Title Number of Ovarian Stimulation Days
Hide Description Ovarian stimulation included from first r-hFSH injection (S1) until day on which r-hCG was administered (r-hCG day).
Time Frame Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 45 47
Mean (Standard Deviation)
Unit of Measure: days
9.4  (1.3) 8.8  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection r-hFSH + r-hLH, r-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0648
Comments [Not Specified]
Method Wilcoxon two sample test
Comments [Not Specified]
15.Secondary Outcome
Title Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)
Hide Description [Not Specified]
Time Frame Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 45 47
Mean (Standard Deviation)
Unit of Measure: IU
2916.1  (555.9) 2861.7  (693.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection r-hFSH + r-hLH, r-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6799
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
16.Secondary Outcome
Title Estradiol (E2) Levels on r-hCG Day
Hide Description [Not Specified]
Time Frame r-hCG day (end of stimulation cycle [approximately 9 days])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication."N" (number of participants analyzed) signifies those participants with plasma E2 levels at r-hCG day.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 40 43
Mean (Standard Deviation)
Unit of Measure: picogram/milliter (pg/mL)
1813.9  (1063.6) 1362.9  (774.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection r-hFSH + r-hLH, r-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0634
Comments [Not Specified]
Method Wilcoxon two sample test
Comments [Not Specified]
17.Secondary Outcome
Title Follicular Levels of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and Human Chorionic Gonadotropin (hCG) at Ovum Pick up (OPU)
Hide Description [Not Specified]
Time Frame OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: milli international unit (mIU)/mL
LH levels at OPU 1.8  (0.9) 2.0  (0.9)
FSH levels at OPU 8.3  (3.0) 9.0  (3.7)
hCG levels at OPU 142.2  (72.7) 136.2  (65.8)
18.Secondary Outcome
Title Follicular Levels of Estradiol (E2) at Ovum Pick up (OPU)
Hide Description [Not Specified]
Time Frame OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: pg/mL
454508.0  (189835.8) 349605.3  (203895.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection r-hFSH + r-hLH, r-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0166
Comments [Not Specified]
Method Wilcoxon two sample test
Comments [Not Specified]
19.Secondary Outcome
Title Follicular Levels of Testosterone (T) at Ovum Pick up (OPU)
Hide Description [Not Specified]
Time Frame OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description:
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: nanogram/milliliter (ng/mL)
5.9  (1.5) 6.0  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection r-hFSH + r-hLH, r-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8812
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame S1 up to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])
Adverse Event Reporting Description An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
 
Arm/Group Title r-hFSH + r-hLH r-hFSH
Hide Arm/Group Description Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once. Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
All-Cause Mortality
r-hFSH + r-hLH r-hFSH
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
r-hFSH + r-hLH r-hFSH
Affected / at Risk (%) Affected / at Risk (%)
Total   2/45 (4.44%)   0/47 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Ectopic pregnancy *  2/45 (4.44%)  0/47 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
r-hFSH + r-hLH r-hFSH
Affected / at Risk (%) Affected / at Risk (%)
Total   1/45 (2.22%)   0/47 (0.00%) 
Gastrointestinal disorders     
Vomiting *  1/45 (2.22%)  0/47 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01079949     History of Changes
Other Study ID Numbers: 27262
2006-005268-19 ( EudraCT Number )
First Submitted: March 2, 2010
First Posted: March 3, 2010
Results First Submitted: November 12, 2012
Results First Posted: February 20, 2013
Last Update Posted: February 27, 2014