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

Organon

Status: Completed

Conditions: Neonates; Pregnancy

Treatments: Drug: ganirelix; Drug: GnRH agonist

Study type: Observational

Funder types: Industry

Identifiers

NCT00724789

38644

P05966

Details and patient eligibility

About

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.

Enrollment: 2,066 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No 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.

Exclusion criteria

• None

Trial design

2,066 participants in 2 patient groups

Observational Cohort

Description:

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.

Treatment:

Drug: ganirelix

Historical Controls

Description:

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

Treatment:

Drug: GnRH agonist