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

NCT ID: NCT00724789

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2066 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2005-11-30

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.

Conditions

Pregnancy; Neonates

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

ganirelix

Intervention Type: DRUG

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

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

GnRH agonist

Intervention Type: DRUG

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

Interventions

ganirelix

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

Intervention Type: DRUG

GnRH agonist

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

Intervention Type: DRUG

Other Intervention Names

Orgalutran; Org 37462

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Bonduelle M, Oberye J, Mannaerts B, Devroey P. Large prospective, pregnancy and infant follow-up trial assures the health of 1000 fetuses conceived after treatment with the GnRH antagonist ganirelix during controlled ovarian stimulation. Hum Reprod. 2010 Jun;25(6):1433-40. doi: 10.1093/humrep/deq072. Epub 2010 Apr 8.

Reference Type: DERIVED

PMID: 20378616 (View on PubMed)

Other Identifiers

38644

Identifier Type: -

Identifier Source: secondary_id

P05966

Identifier Type: -

Identifier Source: org_study_id