An Open-label, Observational Trial to Monitor the Incidence of Congenital Malformations in Infants of Women With an Ongoing Pregnancy After Controlled Ovarian Hyperstimulation Using Puregon® (recFSH)/Orgalutran® (Ganirelix) Followed by IVF/ICSI, or a Long Protocol With a GnRH Agonist as Historical Controls.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 2,066
- Primary Endpoint
- To collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian hyperstimulation.
Study Overview
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 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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
- •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
- Not provided
Arms & Interventions
Observational Cohort
Subjects with an ongoing pregnancy after controlled ovarian stimulations with recombinant follicle stimulating hormone/ganirelix followed by in vitro fertilization or intra cytoplasmatic sperm injection.
Intervention: ganirelix (Drug)
Historical Controls
Subjects with an ongoing pregnancy after controlled ovarian stimulations with recombinant follicle stimulating hormone in a long protocol with a gonadotropin releasing hormone agonist followed by IVF or ICSI
Intervention: GnRH agonist (Drug)
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
Secondary Outcomes
No secondary outcomes reported