Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 107010 (Study 107011)(COMPLETED)(P05713) (Care)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00702338

First received: June 18, 2008

Last updated: October 16, 2009

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	June 18, 2008
Last Updated Date	October 16, 2009
Start Date ^ICMJE	August 2006
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 19, 2008)	Prenatal diagnosis; Mode of delivery; Neonatal outcome; Safety assessment subjects/mothers and newborns/infants; Major/minor congenital malformations [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00702338 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 107010 (Study 107011)(COMPLETED)(P05713)
Official Title ^ICMJE	Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Ovulation Induction in Clinical Trial 107010 for the Development of Org 36286 (Corifollitropin Alfa).
Brief Summary	The objective of this trial is to evaluate whether Org 36286 treatment for the induction of monofollicular growth in women undergoing ovulation induction (OI) is safe for pregnant subjects and their offspring.
Detailed Description	Trial 107010 included two separate stages (Ia+Ib and II). Stage Ia was open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of Org 36286 followed by daily low dose recFSH would provide an appropriate response in eligible subjects meeting all inclusion and none of the exclusion criteria. Stage Ib was open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of Org 36286 followed by daily low dose hCG would provide an appropriate response in eligible subjects meeting all inclusion and none of the exclusion criteria. Stage II was open-label and randomized (n=40) to evaluate whether the intended dosing regimen of Org 36286 followed by low dose FSH (n=20) or hCG (n=20)would provide an appropriate response in eligible subjects meeting all inclusion and none of the exclusion criteria. This was a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who became ongoing pregnant during Trial 107010. For this trial, no study specific assessments were required, but information as obtained in standard practice was used.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Women with an ongoing pregnancy at least 10 weeks after bolus injection of hCG in trial 107010
Condition ^ICMJE	Pregnancy Neonates
Intervention ^ICMJE	Drug: Org 36286 (corifollitropin alfa) and 200 IU hCG Eligible subjects will receive a subcutaneous injection of Org 36286 (stage Ib/II: 30 ug) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient the subject will receive a second or third dose of Org 36286 (stage Ib/II: 20 ug). As soon as the largest follicle reaches a size of 12 mm the subject will start daily injections with hCG (stage Ib/II: 200 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is >= 18 mm and in total no more than two follicles >= 15 mm are observed. Other Name: Corifollitropin alfa Drug: Org 36286 (corifollitropin alfa) and 50IU/75IU recFSH Eligible subjects will receive a subcutaneous injection of Org 36286 (stage Ia:15 ug) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient the subject will receive a second or third dose of Org 36286 (stage Ia: 15 ug). As soon as the largest follicle reaches a size of 12 mm the subject will start daily injections with FSH (stage Ia: 50 IU, stage II: 75 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is >= 18 mm and in total no more than two follicles >= 15 mm are observed.
Study Group/Cohort (s)	Trial 107010 Group 1 Org 36286 and 200 IU hCG Intervention: Drug: Org 36286 (corifollitropin alfa) and 200 IU hCG Trial 107010 Group 2 Org 36286 and 50IU/75IU recFSH Intervention: Drug: Org 36286 (corifollitropin alfa) and 50IU/75IU recFSH
Publications *	Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. Epub 2012 May 15.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1
Completion Date	September 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjects who participated in trial 107010 and received at least one dose of Org 36286; Ongoing pregnancy confirmed by ultrasound at least 10 weeks after bolus injection of hCG in Trial 107010; Able and willing to give written informed consent (informed consent is incorporated in the informed consent form of protocol 107010). Exclusion Criteria: None
Gender	Female
Ages	18 Years to 39 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00702338
Other Study ID Numbers ^ICMJE	107011, EudraCT #: 2006-000967-26, P05713
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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