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

NCT00724789 | Completed

• 2 other identifiers: P0596638644
• Study Type: observational
• Target: 2,066
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

ganirelix DRUG

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

Also known as: Orgalutran, Org 37462

Observational Cohort

GnRH agonist DRUG

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

Historical Controls

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Single site study; A total of approximately 2000 infants born after IVF or ICSI: app. 1000 infants born after ongoing pregnancies resulting from COH including Puregon/Orgalutran treatment followed by IVF or ICSI and app. 1000 infants born after treatment with a long agonist protocol followed by IVF or ICSI as controls.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 20378616 DERIVED

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

ganirelix; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: November 1, 2000
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: February 3, 2022

Record last verified: 2022-02