Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702234
First received: June 18, 2008
Last updated: April 9, 2015
Last verified: April 2015
Results First Received: April 9, 2015  
Study Type: Observational
Study Design: Time Perspective: Prospective
Conditions: Pregnancy
Neonates
Interventions: Biological: Corifollitropin alfa
Biological: GnRH antagonist
Biological: (rec)hCG
Biological: FSH
Drug: Progesterone

  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
Of 272 participants with ongoing pregnancy at 10 weeks after fresh embryo transfer (ET) in base study P05714 (NCT00696878), 268 enrolled in this follow-up study P05715. A participant could enter follow-up study without meeting formal definition for "Completion" of base study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
To complete base study P05714 (NCT00696878), a participant must have embryo transfer in the 3rd Controlled Ovarian Stimulation (COS) cycle (Treatment Cycle 3). For this follow-up trial P05715, study completion for participant (expectant mother) or live born infant was defined as completion of infant follow-up visit at 4-12 weeks after delivery.

Reporting Groups
  Description
Women/Expectant Mothers - Corifollitropin Alfa 150 µg In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
Fetuses Present at 10 Weeks After Fresh ET in Base Study This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.

Participant Flow for 3 periods

Period 1:   Base Study (NCT00696878)
    Women/Expectant Mothers - Corifollitropin Alfa 150 µg     Fetuses Present at 10 Weeks After Fresh ET in Base Study  
STARTED     682     0  
COMPLETED     178     0  
NOT COMPLETED     504     0  

Period 2:   Follow-up Study: Expectant Mothers
    Women/Expectant Mothers - Corifollitropin Alfa 150 µg     Fetuses Present at 10 Weeks After Fresh ET in Base Study  
STARTED     268 [1]   0  
COMPLETED     246     0  
NOT COMPLETED     22     0  
[1] A participant could enter follow-up study without meeting definition for "Completion" of base study

Period 3:   Follow-up Study: Fetuses/Infants
    Women/Expectant Mothers - Corifollitropin Alfa 150 µg     Fetuses Present at 10 Weeks After Fresh ET in Base Study  
STARTED     0     315 [1]
Live Born Infants     0     304 [2]
COMPLETED     0     288 [3]
NOT COMPLETED     0     27  
[1] Fetuses present 10 weeks after fresh ET and/or at enrollment of expectant mother in follow-up study
[2] Of the 11 that were not live born infants, outcome is known for 8 (fetus was lost) and unknown for 3
[3] All 288 who completed were live born infants



  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.
Individuals who participated in base study P05714 (NCT00696878) and received at least one dose of corifollitropin alfa, who had an ongoing pregnancy confirmed by ultrasound at least 10 weeks after fresh ET in base study P05714 and were able and willing to give written informed consent to be enrolled in the follow-up study.

Reporting Groups
  Description
Expectant Mothers - Corifollitropin Alfa 150 µg In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.

Baseline Measures
    Expectant Mothers - Corifollitropin Alfa 150 µg  
Number of Participants  
[units: participants]
  268  
Age  
[units: years]
Mean (Standard Deviation)
  32.8  (3.3)  
Gender  
[units: participants]
 
Female     268  
Male     0  



  Outcome Measures
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1.  Primary:   Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate)   [ Time Frame: Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878) ]

2.  Primary:   Number of Expectant Mothers Experiencing Adverse Events (AEs)   [ Time Frame: From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months) ]

3.  Primary:   Number of Expectant Mothers Experiencing Serious AEs (SAEs)   [ Time Frame: From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months) ]

4.  Primary:   Number of Live Born Infants Experiencing AEs   [ Time Frame: Up to 12 weeks after birth ]

5.  Primary:   Number of Live Born Infants Experiencing SAEs   [ Time Frame: Up to 12 weeks after birth ]


  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.
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: NCT00702234     History of Changes
Other Study ID Numbers: P05715, 2004-004967-30, 38829, MK-8962-008
Study First Received: June 18, 2008
Results First Received: April 9, 2015
Last Updated: April 9, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: National Health Surveillance Agency
Chile: Instituto de Salud Pública de Chile
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency