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

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00724789

Collaborator

(none)

2,066

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Neonates	Drug: ganirelix Drug: GnRH agonist

Study Design

Study Type:

Observational

Actual Enrollment :

2066 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 :

Nov 1, 2000

Actual Primary Completion Date :

Nov 1, 2005

Actual Study Completion Date :

Nov 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: ganirelix Daily 0.25 mg ganirelix administered to prevent premature LH surges during COS in order to achieve a pregnancy Other Names: Orgalutran Org 37462
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	Drug: GnRH agonist Long protocol of GnRH agonist administered to prevent premature LH surges during COS in order to achieve a pregnancy

Arm

Intervention/Treatment

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.

Drug: ganirelix

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

Other Names:

Orgalutran

Org 37462

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

Drug: GnRH agonist

Long protocol of GnRH agonist administered to prevent premature LH surges during COS in order to achieve a pregnancy

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.