A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique

This study has been terminated.
(Study was terminated as per sponsor's decision)
Sponsor:
Collaborator:
Merck Serono Middle East FZ LLC
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01497197
First received: December 20, 2011
Last updated: October 12, 2015
Last verified: October 2015
Results First Received: June 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Infertility
Fertility
Follicle Stimulating Hormone Deficiency
Interventions: Drug: GONAL-f®
Drug: Luveris®
Biological: Recombinant human chorionic gonadotropin (r-hCG)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Gonal-f®+Luveris GONAL f® (Liquid Pen; 300 international units [IU] of per day) stimulation Day 1-5 then followed by Luveris® (vial/powder, 150 IU per day) from stimulation Day 1 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject’s ovarian response and according to the centre's standard practice.
Gonal-f® Followed by Luveris GONAL-f® (Liquid Pen; 300 IU per day) stimulation Day 1-5 then added Luveris® (vial/powder, 150 IU per day) from stimulation day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject’s ovarian response and according to the centre's standard practice.

Participant Flow:   Overall Study
    Gonal-f®+Luveris     Gonal-f® Followed by Luveris  
STARTED     89     85  
COMPLETED     72     70  
NOT COMPLETED     17     15  
Lost to Follow-up                 1                 0  
Protocol Violation                 0                 2  
Withdrawal by Subject                 2                 1  
Excessive/lack of response to treatment                 1                 0  
Risk of OHSS                 1                 0  
No oocytes retrieved                 3                 2  
No fertilisation                 6                 5  
Intention to freeze all embryos                 0                 1  
All embryos discarded                 0                 3  
Unspecified                 3                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline analysis population included all the subjects randomized in the study.

Reporting Groups
  Description
Gonal-f®+Luveris GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Gonal-f® Followed by Luveris GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Total Total of all reporting groups

Baseline Measures
    Gonal-f®+Luveris     Gonal-f® Followed by Luveris     Total  
Number of Participants  
[units: participants]
  89     85     174  
Age  
[units: years]
Mean (Standard Deviation)
  37.8  (1.6)     38  (1.7)     37.9  (1.65)  
Gender  
[units: subjects]
     
Female     89     85     174  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation   [ Time Frame: 34-38 hours post r-hCG administration ]

2.  Secondary:   Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)   [ Time Frame: Screening ]

3.  Secondary:   Total Number of Stimulation Treatment Days   [ Time Frame: 6 days post stimulation (Number of stimulation days+6 days) ]

4.  Secondary:   Implantation Rate   [ Time Frame: 35-42 days post r-hCG administration ]

5.  Secondary:   Number of Fetal Sacs With Activity   [ Time Frame: 35-42 days post r-hCG administration ]

6.  Secondary:   Number of Fetal Sacs With Detectable Heart Beats   [ Time Frame: 35-42 days post r-hCG administration ]

7.  Secondary:   Total Pregnancy Rate and Clinical Pregnancy Rate   [ Time Frame: 35-42 days post r-hCG administration ]

8.  Secondary:   Cycle Cancellation Rate Prior to r-hCG   [ Time Frame: Up to 85 days ]

9.  Secondary:   Number of Subjects With Biochemical Pregnancies   [ Time Frame: 35 to 42 days post r-hCG administration ]

10.  Secondary:   Number of Subjects With Multiple Pregnancies   [ Time Frame: 35 to 42 days post r-hCG administration ]

11.  Secondary:   Number of Subjects With Any Adverse Events (AEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation   [ Time Frame: Baseline up to 15-20 days post r-hCG administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Study was terminated as per sponsor's decision.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: service@merckgroup.com



Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01497197     History of Changes
Other Study ID Numbers: EMR200061-506
Study First Received: December 20, 2011
Results First Received: June 15, 2015
Last Updated: October 12, 2015
Health Authority: United Arab Emirates: Ministry of Health