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

Organon

Status: Completed

Conditions: Pregnancy

Treatments: Drug: recFSH; Drug: Placebo; Drug: Org 36286 (corifollitropin alfa)

Study type: Observational

Funder types: Industry

Identifiers

NCT00702195

38817

P06054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No 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.

Exclusion criteria

• None

Trial design

29 participants in 4 patient groups

Experimental Group 1

Description:

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

Treatment:

Drug: Org 36286 (corifollitropin alfa)

Experimental Group 2

Description:

Placebo

Treatment:

Drug: Placebo

Experimental Group 3

Description:

all doses of Org 36286 (corifollitropin alfa) from trial 38807 (120 μg, 180 μg and 240 μg)

Treatment:

Drug: Org 36286 (corifollitropin alfa)

Experimental Group 4

Description:

150 IU Puregon®

Treatment:

Drug: recFSH