Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713) (Care)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702338
First received: June 18, 2008
Last updated: May 14, 2014
Last verified: May 2014
Results First Received: March 31, 2014  
Study Type: Observational
Study Design: Time Perspective: Prospective
Conditions: Pregnancy
Neonates
Interventions: Drug: corifollitropin alfa
Biological: recombinant Follicle Stimulating Hormone (recFSH)
Biological: human Chorion Gonadotropin (hCG)
Biological: hCG Bolus injection

  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 treated with either corifollitropin alfa + recombinant Follicular Stimulating Hormone (recFSH) or corifollitropin alfa + Human Chorion Gonadotropin (hCG) in P05693 (NCT00697255) and with an ongoing pregnancy were to be recruited for the following study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 8 participants treated with corifollitropin alfa + recFSH (5) or hCG (3) in base study P05693 (NCT00697255), one participant from the corifollitropin alfa + hCG group was enrolled in the current follow-up study with an ongoing multiple pregnancy. No participants from the corifollitropin alfa + recFSH group enrolled in the current follow-up study

Reporting Groups
  Description
Corifollitropin Alfa + recFSH Mothers Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
Corifollitropin Alfa + hCG Mothers Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
Corifollitropin Alfa + hCG FU-Infants Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.

Participant Flow for 3 periods

Period 1:   Base Study (NCT00697255)
    Corifollitropin Alfa + recFSH Mothers     Corifollitropin Alfa + hCG Mothers     Corifollitropin Alfa + hCG FU-Infants  
STARTED     5     3     0  
COMPLETED     2 [1]   1 [1]   0  
NOT COMPLETED     3     2     0  
[1] To complete the study, participants must have received hCG bolus injection.

Period 2:   Follow-up Study: Expectant Mothers FU
    Corifollitropin Alfa + recFSH Mothers     Corifollitropin Alfa + hCG Mothers     Corifollitropin Alfa + hCG FU-Infants  
STARTED     0 [1]   1 [1]   0  
COMPLETED     0     0 [2]   0  
NOT COMPLETED     0     1     0  
[1] To enroll in follow-up study, confirmed pregnancy at ≥10 wks after hCG bolus injection was required
[2] To complete the study, participants must have completed a follow-up visit at 4-12 weeks postpartum.

Period 3:   Follow-up Study: Infant FU
    Corifollitropin Alfa + recFSH Mothers     Corifollitropin Alfa + hCG Mothers     Corifollitropin Alfa + hCG FU-Infants  
STARTED     0     0     2 [1]
COMPLETED     0     0     0  
NOT COMPLETED     0     0     2  
[1] Participants died on day of delivery, did not complete follow-up visit at 4-12 weeks postpartum.



  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.
The Baseline Analysis Population consisted of one mother with confirmed pregnancy who was treated with corifollitropin alfa + hCG in base study P05693 (NCT00697255) and enrolled in the current follow-up study. Baseline characteristics were not summarized for the infants born on study.

Reporting Groups
  Description
Corifollitropin Alfa + hCG Mothers Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).

Baseline Measures
    Corifollitropin Alfa + hCG Mothers  
Number of Participants  
[units: participants]
  1  
Age  
[units: years]
Mean ± Standard Deviation
  31  ± 0  
Gender  
[units: participants]
 
Female     1  
Male     0  



  Outcome Measures
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1.  Primary:   Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined   [ Time Frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year) ]

2.  Primary:   Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis   [ Time Frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year) ]

3.  Primary:   Number of Mothers With Adverse Events (AEs) During Follow-up   [ Time Frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year) ]

4.  Primary:   Number of Mothers With Serious AEs (SAEs) During Follow-up   [ Time Frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year) ]

5.  Primary:   Number of Infants With AEs During Follow-up   [ Time Frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study ]

6.  Primary:   Number of Infants With SAEs During Follow-up   [ Time Frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study ]


  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
phone: 1-800-672-6372
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: NCT00702338     History of Changes
Other Study ID Numbers: P05713, 2006-000967-26, 107011, MK-8962-006
Study First Received: June 18, 2008
Results First Received: March 31, 2014
Last Updated: May 14, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)