Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-01-04 @ 7:08 AM
Study NCT ID:
NCT00702195
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2008-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)
Sponsor:
Organon and Co
Organization:
Study Overview
Official Title:
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials for the Development of Org 36286 (Corifollitropin Alfa).
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 38817 | None | None | View |