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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00724789

Enrollment

2066

Registered

2008-07-30

Start date

2000-11-30

Completion date

2005-11-30

Last updated

2022-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonates, Pregnancy

Keywords

Neonatal outcome, Congenital malformations, In-Vitro fertilization, Controlled ovarian stimulation, Follow-up

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.

Interventions

DRUGganirelix

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

DRUGGnRH agonist

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 39 Years

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

Design outcomes

Primary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026