Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00702195

Purpose

The objective of this trial was to evaluate whether Org 36286 treatment in any Phase IIa clinical development trial of Org 36286 for OI or COH in assisted reproductive treatment programs was safe for pregnant subjects and their offspring. Data from subjects who participated in Trials 38805 and 38807 and became pregnant were evaluated.

Condition	Intervention
Pregnancy	Drug: Org 36286 (corifollitropin alfa) Drug: Placebo Drug: recFSH

Drug Information available for: Follitropin beta Urofollitropin Corifollitropin alfa Follicle Stimulating Hormone

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials for the Development of Org 36286 (Corifollitropin Alfa).

Further study details as provided by Organon:

Primary Outcome Measures:

Pregnancy status at 20 weeks of gestation; Take-home baby rate [ Time Frame: one pregnancy period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pregnancy follow-up; Delivery follow-up; Neonatal outcome; Infant follow-up; Congenital Malformations and Chromosomal Abnormalities [ Time Frame: one pregnancy period ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	29
Study Start Date:	January 2002
Study Completion Date:	September 2003
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Experimental Group 1 all doses of Org 36286 (corifollitropin alfa) from trial 38805 (7.5 μg, 15 μg, 30 μg and 60 μg)	Drug: Org 36286 (corifollitropin alfa) single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807
Experimental Group 2 Placebo	Drug: Placebo single dose of placebo (administered under protocol 38805)
Experimental Group 3 all doses of Org 36286 (corifollitropin alfa) from trial 38807 (120 μg, 180 μg and 240 μg)	Drug: Org 36286 (corifollitropin alfa) single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807
Experimental Group 4 150 IU Puregon®	Drug: recFSH 150 IU recFSH daily (reference group administered under protocol 38807)

Detailed Description:

This was an open prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during any Phase IIa clinical trial of Org 36286 for OI or COH for IVF. For this trial, no study specific assessments were required, but information obtained in standard practice was used.

Eligibility

Ages Eligible for Study:	18 Years to 39 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All women who became pregnant during Trials 38805 or 38807 were enrolled in Trial 38817

Criteria

Inclusion Criteria:

Subjects taking part in any clinical development trial of Org 36286 for OI or COH for IVF in Phase IIa;
Ongoing pregnancy confirmed by ultrasonography (USS) at or beyond 12 weeks of gestation;
Able and willing to give written informed consent.

Exclusion Criteria:

None

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	38817
Study First Received:	June 18, 2008
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00702195
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Organon:

Neonatal outcome
Congenital malformations
In-Vitro Fertilization
Controlled ovarian stimulation

Follow-up
Ovulation Induction
Neonates

Study placed in the following topic categories:

Congenital Abnormalities
Follicle Stimulating Hormone

ClinicalTrials.gov processed this record on January 15, 2009