Monitor the Incidence of Congenital Malformations in Infants of Women Who Have Been Treated With Ganirelix (Orgalutran®)(Study 38644)(P05966)(COMPLETED)

Organon and Co2,066 enrolled

Overview

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 follicle stimulating hormone /ganirelix followed by in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI), and to compare this incidence with that of a group of women who used a long protocol with a gonadotropin releasing hormone agonist as historical controls.

Study Type

OBSERVATIONAL

Enrollment

2,066

Conditions

Pregnancy Neonates

Interventions

ganirelixDRUG

Daily 0.25 mg ganirelix administered to prevent premature LH surges during COS in order to achieve a pregnancy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * None

Outcomes

Primary Outcomes

To collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian hyperstimulation.

Time frame: In both cohorts a follow-up pediatric evaluation was scheduled within 6 months post-partum