Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)(P06056)(COMPLETED)
February 1, 2022 updated by: Organon and Co
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 for the Development of Org 36286 (Corifollitropin Alfa).
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.
Study Overview
Status
Completed
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 Trial 38826.
For this trial, no study specific assessments were required, but information obtained in standard practice was used.
Study Type
Observational
Enrollment (Actual)
44
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
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women with an ongoing pregnancy at least 10 weeks after embryo transfer in Trial 38826 were enrolled in this trial.
Description
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
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) (60 μg, 120 μg and 180 μg)
|
single dose of 60, 120, or 180 μg Org 36286 (experimental group administered under protocol 38826)
Other Names:
|
|
Experimental Group 2
150 IU recFSH
|
150 IU recFSH daily (reference group administered under protocol 38826)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pregnancy status at 20 weeks of gestation
Time Frame: one pregnancy period
|
one pregnancy period
|
|
Take-home baby rate
Time Frame: one pregnancy period
|
one pregnancy period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pregnancy follow-up
Time Frame: one pregnancy period
|
one pregnancy period
|
|
Delivery follow-up
Time Frame: one pregnancy period
|
one pregnancy period
|
|
Neonatal outcome
Time Frame: one pregnancy period
|
one pregnancy period
|
|
Infant follow-up
Time Frame: one pregnancy period
|
one pregnancy period
|
|
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)
October 1, 2003
Primary Completion (Actual)
February 28, 2005
Study Completion (Actual)
February 28, 2005
Study Registration Dates
First Submitted
June 18, 2008
First Submitted That Met QC Criteria
June 18, 2008
First Posted (Estimate)
June 20, 2008
Study Record Updates
Last Update Posted (Actual)
February 3, 2022
Last Update Submitted That Met QC Criteria
February 1, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P06056
- 38827
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.