PERgoveriS In Stratified Treatment for Assisted Reproductive Technique (PERSIST)
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ClinicalTrials.gov Identifier: NCT01297465 |
Recruitment Status :
Completed
First Posted : February 16, 2011
Results First Posted : February 24, 2014
Last Update Posted : February 24, 2014
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Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborators:
Merck Serono S.A., Geneva
Merck A/S, Denmark
Merck OY, Finland
Merck Serono S.A.S, France
Merck Serono GmbH, Germany
Merck A.E., Greece
Merck B.V., Netherlands
Merck SP. Z.O.O., Poland
Merck Serono S.P.A., Italy
Merck Services U.K. Ltd, UK
LLC Merck, Russia
Merck spol. s r.o., Slovakia
Merck Pharma, K.S., Slovakia
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Assisted Reproductive Techniques Reproductive Technology, Assisted |
Interventions |
Drug: Gonal-f® Drug: Pergoveris® Drug: Recombinant human chorionic gonadotropin (r-hCG) |
Enrollment | 202 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Gonal-f® Plus Pergoveris® | Pergoveris® |
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Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice. | Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice. |
Period Title: Overall Study | ||
Started | 99 | 103 |
Completed | 91 | 93 |
Not Completed | 8 | 10 |
Reason Not Completed | ||
Lack of Ovarian Response | 1 | 1 |
Ovarian hyperstimulation syndrome risk | 0 | 1 |
No Oocytes Retrieved | 1 | 1 |
Poor oocyte quality | 0 | 1 |
No Fertilization | 6 | 4 |
All Embryos Discarded | 0 | 1 |
Intention to Freeze all Embryos | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Gonal-f® Plus Pergoveris® | Pergoveris® | Total | |
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Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice. | Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice. | Total of all reporting groups | |
Overall Number of Baseline Participants | 99 | 103 | 202 | |
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Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 99 participants | 103 participants | 202 participants | |
37.6 (1.16) | 37.4 (1.14) | 37.5 (1.15) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 99 participants | 103 participants | 202 participants | |
Female |
99 100.0%
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103 100.0%
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202 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Race
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 99 participants | 103 participants | 202 participants |
Black | 4 | 3 | 7 | |
Asian | 4 | 6 | 10 | |
Other | 2 | 2 | 4 | |
White | 89 | 92 | 181 | |
Height
Mean (Standard Deviation) Unit of measure: Centimeter |
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Number Analyzed | 99 participants | 103 participants | 202 participants | |
166.1 (6.49) | 166.3 (6.47) | 166.2 (6.46) | ||
Weight
Mean (Standard Deviation) Unit of measure: Kilogram |
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Number Analyzed | 99 participants | 103 participants | 202 participants | |
64.81 (10.364) | 65.82 (8.923) | 65.33 (9.645) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Merck KGaA Communication Center |
Organization: | Merck Serono, a division of Merck KGaA |
Phone: | +49-6151-72-5200 |
EMail: | service@merckgroup.com |
Publications of Results:
H Behre, C Howles, S Longobardi. Luteinizing hormone supplementation from Day 1 versus 6 of ovarian stimulation in women aged 36-40 years: results from an open-label, randomized, multicentre, multinational trial. Human Reproduction. 2013;28(suppl 1)
Responsible Party: | Merck KGaA, Darmstadt, Germany |
ClinicalTrials.gov Identifier: | NCT01297465 |
Other Study ID Numbers: |
EMR 200061-504 2010-023534-23 ( EudraCT Number ) |
First Submitted: | February 15, 2011 |
First Posted: | February 16, 2011 |
Results First Submitted: | October 23, 2013 |
Results First Posted: | February 24, 2014 |
Last Update Posted: | February 24, 2014 |