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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702195
• Other study ID #: P06054
• Secondary ID: 38817
• Status: Completed
• Start date: January 1, 2002
• Est. completion date: September 15, 2003

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 15, 2003
• Est. primary completion date: September 15, 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Org 36286 (corifollitropin alfa)
single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807
• Placebo
single dose of placebo (administered under protocol 38805)
• recFSH
150 IU recFSH daily (reference group administered under protocol 38807)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy status at 20 weeks of gestation; Take-home baby rate		one pregnancy period
Secondary	Pregnancy follow-up; Delivery follow-up; Neonatal outcome; Infant follow-up; Congenital Malformations and Chromosomal Abnormalities		one pregnancy period