Monitor the Incidence of Congenital Malformations in Infants of Women Who Have Been Treated With Ganirelix (Orgalutran®)(Study 38644)(P05966)(COMPLETED)
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|ClinicalTrials.gov Identifier: NCT00724789|
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : July 14, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment|
|Pregnancy Neonates||Drug: ganirelix Drug: GnRH agonist|
|Study Type :||Observational|
|Actual Enrollment :||2066 participants|
|Official Title:||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.|
|Study Start Date :||November 2000|
|Actual Primary Completion Date :||November 2005|
|Actual Study Completion Date :||November 2005|
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.
Daily 0.25 mg ganirelix administered to prevent premature LH surges during COS in order to achieve a pregnancy
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
Long protocol of GnRH agonist administered to prevent premature LH surges during COS in order to achieve a pregnancy
Primary Outcome Measures :
- 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 ]
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