Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 107012 (Care Program) (Study 107014)
Information source: Organon
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy; Neonates
Intervention: Org 36286 (Drug); recFSH (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Organon
Summary
The objective of this trial is to evaluate whether Org 36286 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) is safe for pregnant
subjects and their offspring.
Clinical Details
Official title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 107012 for the Development of Org 36286 (Corifollitropin Alfa).
Study design: Other, Prospective
Primary outcome: Prenatal diagnosis; Mode of delivery; Neonatal outcome; Safety assessment subjects/mothers and newborns/infants; Major/minor congenital malformations
Detailed description:
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal
outcome of women who were treated with Org 36286 or recFSH and became pregnant during Trial
107012. For this trial no study specific assessments are required, but information as
obtained in standard practice will be used.
Eligibility
Minimum age: 18 Years.
Maximum age: 36 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Subjects who participated in trial 107012 and received at least one dose of either Org
36286 or Puregon®/Follistim® AQ Cartridge in trial 107012;
- Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in
Trial 107012;
- Able and willing to give written informed consent.
Exclusion Criteria:
- None
Locations and Contacts
Additional Information
Starting date: April 2007
Ending date: October 2008
Last updated: June 18, 2008
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