Predictive Factors for Ovarian Stimulation Using a Fixed Daily Dose of 200 IU Recombinant FSH (Study 142003)(P05696) (Xpect)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00778999
First received: October 23, 2008
Last updated: May 6, 2014
Last verified: May 2014
Results First Received: June 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Infertility
Intervention: Drug: Marvelon

  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
Oral Contraceptive Use of oral contraceptive pills prior to controlled ovarian stimulation
Non-Oral Contraceptive No use of oral contraceptive pills prior to controlled ovarian stimulation

Participant Flow:   Overall Study
    Oral Contraceptive     Non-Oral Contraceptive  
STARTED     223     219  
COMPLETED     195     185  
NOT COMPLETED     28     34  
Discontinuation: no embryo transfer                 14                 14  
Did not receive recFSH                 14                 20  



  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.
No text entered.

Reporting Groups
  Description
Oral Contraceptive Use of oral contraceptive pills prior to controlled ovarian stimulation
Non-Oral Contraceptive No use of oral contraceptive pills prior to controlled ovarian stimulation
Total Total of all reporting groups

Baseline Measures
    Oral Contraceptive     Non-Oral Contraceptive     Total  
Number of Participants  
[units: participants]
  223     219     442  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     223     219     442  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     223     219     442  
Male     0     0     0  



  Outcome Measures

1.  Primary:   Total Number of Oocytes   [ Time Frame: 12 weeks ]

2.  Secondary:   Number of Mature Oocytes   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Number of Follicles on Stimulation Day 8   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Number of Follicles on Day of hCG   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Number of Fertilized (2PN) Oocytes   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Number of Good Quality Embryos   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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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.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00778999     History of Changes
Obsolete Identifiers: NCT00628641
Other Study ID Numbers: P05696, 142003
Study First Received: October 23, 2008
Results First Received: June 23, 2009
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration