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Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38819 for Org 36286 (Corifollitropin Alfa)
The objective of this trial was to evaluate whether Corifollitropin Alfa treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) was safe for pregnant participants and their offspring. The primary endpoint was the take-home baby rate calculated as the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800) with at least one live born infant relative to the number of participants in the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer (ET).
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of all women who were treated with Corifollitropin Alfa or recFSH and became pregnant during Base Trial P05787 (NCT00696800). For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.
Age
18 - 36 years
Sex
FEMALE
Healthy Volunteers
No
Start Date
July 13, 2006
Primary Completion Date
April 18, 2008
Completion Date
March 15, 2009
Last Updated
September 19, 2024
541
ACTUAL participants
Corifollitropin Alfa 150 μg
DRUG
200 IU RecFSH/Follitropin beta (Days 1 to 7)
BIOLOGICAL
Placebo for Corifollitropin Alfa
DRUG
Placebo for RecFSH/Follitropin beta
DRUG
200 IU RecFSH/Follitropin beta (Days 8 to hCG)
BIOLOGICAL
Ganirelix
DRUG
hCG
BIOLOGICAL
Progesterone
BIOLOGICAL
Lead Sponsor
Organon and Co
NCT06768060
NCT07462065
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06273683