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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:
ClinicalTrials.gov Identifier:
NCT00778999
First Posted: October 24, 2008
Last Update Posted: May 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: June 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Overall Participants Analyzed 
[Units: Participants]
 223   219   442 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      223 100.0%      219 100.0%      442 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      223 100.0%      219 100.0%      442 100.0% 
Male      0   0.0%      0   0.0%      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.  

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

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

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

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


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00778999     History of Changes
Obsolete Identifiers: NCT00628641
Other Study ID Numbers: P05696
142003
First Submitted: October 23, 2008
First Posted: October 24, 2008
Results First Submitted: June 23, 2009
Results First Posted: August 12, 2009
Last Update Posted: May 12, 2017