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

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials for the Development of Org 36286 (Corifollitropin Alfa).

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00702195

Enrollment

Registered

2008-06-20

Start date

2002-01-01

Completion date

2003-09-15

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Neonatal outcome, Congenital malformations, In-Vitro Fertilization, Controlled ovarian stimulation, Follow-up, Ovulation Induction, Neonates

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.

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.

Interventions

DRUGOrg 36286 (corifollitropin alfa)

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

DRUGPlacebo

single dose of placebo (administered under protocol 38805)

DRUGrecFSH

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 39 Years

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

Design outcomes

Primary

Measure	Time frame
Pregnancy status at 20 weeks of gestation; Take-home baby rate	one pregnancy period

Secondary

Measure	Time frame
Pregnancy follow-up; Delivery follow-up; Neonatal outcome; Infant follow-up; Congenital Malformations and Chromosomal Abnormalities	one pregnancy period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026