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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Pregnancy, Neonates

Intervention / Treatment
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* Drug: ganirelix
* Drug: GnRH agonist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational Cohort<br>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. | Drug: ganirelix<br>* Daily 0.25 mg ganirelix administered to prevent premature LH surges during COS in order to achieve a pregnancy<br>* Other names: Org 37462;|
| Historical Controls<br>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 | Drug: GnRH agonist<br>* Long protocol of GnRH agonist administered to prevent premature LH surges during COS in order to achieve a pregnancy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian hyperstimulation. |  | In both cohorts a follow-up pediatric evaluation was scheduled within 6 months post-partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal outcome, Congenital malformations, In-Vitro fertilization, Controlled ovarian stimulation, Follow-up