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OpenTrials
Completed

NCT Number: NCT00724789

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

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.

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Key information

Conditions

Pregnancy Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Neonates

Age range

18 year–39 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ganirelix

Drug

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

Other names: Orgalutran, Org 37462

GnRH agonist

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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.

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Jul 30, 2008
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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