Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)(P06056)(COMPLETED)
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 for the Development of Org 36286 (Corifollitropin Alfa).
2 other identifiers
observational
44
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2003
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2005
CompletedFirst Submitted
Initial submission to the registry
June 18, 2008
CompletedFirst Posted
Study publicly available on registry
June 20, 2008
CompletedFebruary 3, 2022
February 1, 2022
1.4 years
June 18, 2008
February 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pregnancy status at 20 weeks of gestation
one pregnancy period
Take-home baby rate
one pregnancy period
Secondary Outcomes (5)
Pregnancy follow-up
one pregnancy period
Delivery follow-up
one pregnancy period
Neonatal outcome
one pregnancy period
Infant follow-up
one pregnancy period
Congenital malformations and chromosomal abnormalities
one pregnancy period
Study Arms (2)
Experimental Group 1
all doses of Org 36286 (corifollitropin alfa) (60 μg, 120 μg and 180 μg)
Experimental Group 2
150 IU recFSH
Interventions
single dose of 60, 120, or 180 μg Org 36286 (experimental group administered under protocol 38826)
150 IU recFSH daily (reference group administered under protocol 38826)
Eligibility Criteria
Women with an ongoing pregnancy at least 10 weeks after embryo transfer in Trial 38826 were enrolled in this trial.
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15.
PMID: 22587997DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2008
First Posted
June 20, 2008
Study Start
October 1, 2003
Primary Completion
February 28, 2005
Study Completion
February 28, 2005
Last Updated
February 3, 2022
Record last verified: 2022-02