Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)
August 13, 2024 updated by: Organon and Co
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials for the Development of Org 36286 (Corifollitropin Alfa).
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
29
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All women who became pregnant during Trials 38805 or 38807 were enrolled in Trial 38817
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Experimental Group 1
all doses of Org 36286 (corifollitropin alfa) from trial 38805 (7.5 μg, 15 μg, 30 μg and 60 μg)
|
single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807
Other Names:
|
|
Experimental Group 2
Placebo
|
single dose of placebo (administered under protocol 38805)
|
|
Experimental Group 3
all doses of Org 36286 (corifollitropin alfa) from trial 38807 (120 μg, 180 μg and 240 μg)
|
single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807
Other Names:
|
|
Experimental Group 4
150 IU Puregon®
|
150 IU recFSH daily (reference group administered under protocol 38807)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pregnancy status at 20 weeks of gestation; Take-home baby rate
Time Frame: one pregnancy period
|
one pregnancy period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pregnancy follow-up; Delivery follow-up; Neonatal outcome; Infant follow-up; Congenital Malformations and Chromosomal Abnormalities
Time Frame: one pregnancy period
|
one pregnancy period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2002
Primary Completion (Actual)
September 15, 2003
Study Completion (Actual)
September 15, 2003
Study Registration Dates
First Submitted
June 18, 2008
First Submitted That Met QC Criteria
June 19, 2008
First Posted (Estimated)
June 20, 2008
Study Record Updates
Last Update Posted (Actual)
August 15, 2024
Last Update Submitted That Met QC Criteria
August 13, 2024
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P06054
- 38817
Plan for Individual participant data (IPD)
Study Data/Documents
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