Status:
COMPLETED
Monitor the Incidence of Congenital Malformations in Infants of Women Who Have Been Treated With Ganirelix (Orgalutran®)(Study 38644)(P05966)(COMPLETED)
Lead Sponsor:
Organon and Co
Conditions:
Pregnancy
Neonates
Eligibility:
FEMALE
18-39 years
Brief Summary
The primary purpose of this study is to collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian stimulation with recombinant fo...
Eligibility Criteria
Inclusion
- Puregon® (recFSH)/Orgalutran® group:
- Women with a pregnancy of \>= 16 weeks after Puregon® /Orgalutran® treatment for IVF or ICSI and ET of fresh embryos. Treatment is defined as having had at least one injection of Orgalutran®.
- Women between 18 and 39 years of age (inclusive) at the day of hCG.
- Women who are able and willing to sign informed consent.
- Controls
- Infants (gestational age \>=16 weeks) of women pregnant after COH using a GnRH agonist in a long protocol for IVF or ICSI and ET of fresh embryos.
- Infants of women between 18 and 39 years of age (inclusive) at the day of hCG.
- The most recent 1000 infants delivered prior to January 1, 2001.
Exclusion
- None
Key Trial Info
Start Date :
November 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
2066 Patients enrolled
Trial Details
Trial ID
NCT00724789
Start Date
November 1 2000
End Date
November 1 2005
Last Update
February 3 2022
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