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A Prospective Study to Evaluate the Addition of Subcutaneous Recombinant Human-Luteinizing Hormone With Recombinant Human-Follicle Stimulating Hormone on Follicular Development in Women Undergoing Ovarian Stimulation for Assisted Reproductive Technologies

This study has been completed.
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT01121991
First received: May 10, 2010
Last updated: June 8, 2011
Last verified: June 2011
History of Changes
Results First Received: February 17, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Infertility
Ovarian Stimulation
Intervention: Drug: Recombinant Human-Luteinizing Hormone (Luveris)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited in 4 study centers in Canada from September 2004 to October 2005.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
55 participants were enrolled in the study, 3 participants discontinued prior to study drug administration as they did not meet the eligibility criteria.

Reporting Groups
  Description
Recombinant Human-Luteinizing Hormone (Luveris) All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.

Participant Flow:   Overall Study
    Recombinant Human-Luteinizing Hormone (Luveris)  
STARTED     52 [1]
COMPLETED     46  
NOT COMPLETED     6  
Lack of Ovarian Response                 2  
No Oocytes Retrieved                 3  
No Fertilization                 1  
[1] Number of participants treated



  Baseline Characteristics
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Reporting Groups
  Description
Recombinant Human-Luteinizing Hormone (Luveris) All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.

Baseline Measures
    Recombinant Human-Luteinizing Hormone (Luveris)  
Number of Participants  
[units: participants]
 		  52  
Age  
[units: years]
Mean ± Standard Deviation 		  34.6  ± 3.6  
Age, Customized  
[units: participants]
 		 
<35 years     22  
>=35 years     30  
Gender  
[units: participants]
 		 
Female     52  
Male     0  
Race/Ethnicity, Customized  
[units: participants]
 		 
Asian     3  
White     47  
Hispanic     1  
Aboriginal     1  
Region of Enrollment  
[units: participants]
 		 
Canada     52  
Smoking [1]
[units: participants]
 		 
0 cigarettes per day     50  
6-20 cigarettes per day     1  
>20 cigarettes per day     1  
[1] Consumption of cigarettes is inclusive of cigarillos and cigars.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Number of Metaphase II Oocytes Per Participant Who Underwent Ovum Pick up for Intra-cytoplasmic Sperm Injection (ICSI)   [ Time Frame: On the day of ovum pick up (Day 1 or 2 after human chorionic gonadotropin [hCG] administration). ]
  Show Outcome Measure 1

2.  Primary:   Mean Number of Mature Oocytes Per Participant Who Underwent Ovum Pick up for In Vitro Fertilization (IVF)   [ Time Frame: On the day of ovum pick up (Day 1 or 2 after hCG administration). ]
  Show Outcome Measure 2

3.  Secondary:   Mean Number of Oocytes Retrieved Per Number of Follicles Aspirated on the Day of Ovum Pick up   [ Time Frame: On day of ovum pick up (Day 1 or 2 after hCG administration) ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies   [ Time Frame: Post-hCG days 15-20 and post-hCG days 35-42. ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With Multiple Pregnancies   [ Time Frame: Post-hCG Day 35-42. ]
  Show Outcome Measure 5

6.  Secondary:   Number of Live Births   [ Time Frame: Post-hCG days 15-20 to pregnancy follow up. ]
  Show Outcome Measure 6

7.  Secondary:   Pregnancy Loss Per Clinical Pregnancy   [ Time Frame: Post-hCG days 35-42. ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation.   [ Time Frame: From stimulation Day 1 (S1) to post-hCG days 35-42 (safety visit). ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Medical Responsible
Organization: EMD Serono Canada Inc., an affiliate of Merck KGaA, Darmstadt, Germany
phone: +1-888-737-6668 ext 5248
e-mail: david.sciberras@emdserono.com


No publications provided


Responsible Party: Irene Kavanagh, Medical Research Manager, EMD Serono Canada Inc., an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01121991     History of Changes
Other Study ID Numbers: IMP 25244
Study First Received: May 10, 2010
Results First Received: February 17, 2011
Last Updated: June 8, 2011
Health Authority: Canada: Health Canada