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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-01

Study Completion Date

2003-09-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental Group 1

all doses of Org 36286 (corifollitropin alfa) from trial 38805 (7.5 μg, 15 μg, 30 μg and 60 μg)

Org 36286 (corifollitropin alfa)

Intervention Type DRUG

single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807

Experimental Group 2

Placebo

Intervention Type DRUG

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)

Org 36286 (corifollitropin alfa)

Intervention Type DRUG

single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807

Experimental Group 4

150 IU Puregon®

recFSH

Intervention Type DRUG

150 IU recFSH daily (reference group administered under protocol 38807)

Interventions

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Org 36286 (corifollitropin alfa)

single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807

Intervention Type DRUG

Placebo

single dose of placebo (administered under protocol 38805)

Intervention Type DRUG

recFSH

150 IU recFSH daily (reference group administered under protocol 38807)

Intervention Type DRUG

Other Intervention Names

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corifollitropin alfa follitropin beta Puregon® Follistim®

Eligibility Criteria

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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.