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

Organon

Status: Completed

Conditions: Neonates; Pregnancy

Treatments: Drug: Org 36286; Drug: recFSH

Study type: Observational

Funder types: Industry

Identifiers

NCT00702988

38827

P06056

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

44 participants in 2 patient groups

Experimental Group 1

Description:

all doses of Org 36286 (corifollitropin alfa) (60 μg, 120 μg and 180 μg)

Treatment:

Drug: Org 36286

Experimental Group 2

Description:

150 IU recFSH

Treatment:

Drug: recFSH