Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00702195

Collaborator

(none)

Enrollment

20.4

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pregnancy	Drug: Org 36286 (corifollitropin alfa) Drug: Placebo Drug: recFSH

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.

Study Design

Study Type:

Observational

Actual Enrollment :

29 participants

Observational Model:

Other

Time Perspective:

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).

Actual Study Start Date :

Jan 1, 2002

Actual Primary Completion Date :

Sep 15, 2003

Actual Study Completion Date :

Sep 15, 2003

Arms and Interventions

Arm	Intervention/Treatment
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 Other Names: corifollitropin alfa
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 Other Names: corifollitropin alfa
Experimental Group 4 150 IU Puregon®	Drug: recFSH 150 IU recFSH daily (reference group administered under protocol 38807) Other Names: follitropin beta Puregon® Follistim®

Outcome Measures

Primary Outcome Measures

Pregnancy status at 20 weeks of gestation; Take-home baby rate [one pregnancy period]

Secondary Outcome Measures

Pregnancy follow-up; Delivery follow-up; Neonatal outcome; Infant follow-up; Congenital Malformations and Chromosomal Abnormalities [one pregnancy period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.