Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)(P06056)(COMPLETED)

Organon and Co44 enrolled

Overview

The objective of this trial was to evaluate whether Org 36286 treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant subjects and their offspring.

This was an open, prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during Trial 38826. For this trial, no study specific assessments were required, but information obtained in standard practice was used.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pregnancy Neonates

Interventions

Org 36286DRUG

single dose of 60, 120, or 180 μg Org 36286 (experimental group administered under protocol 38826)

recFSHDRUG

150 IU recFSH daily (reference group administered under protocol 38826)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who participated in Trial 38826 and became pregnant (as confirmed by USS at or beyond 10 weeks after ET) after having received at least one dose of either Org 36286 or Puregon®; and * Able and willing to give written informed consent. Exclusion Criteria: * None