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

Pregnancy Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724789
• Other study ID #: P05966
• Secondary ID: 38644
• Status: Completed
• Start date: November 2000
• Est. completion date: November 2005

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2066
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Neonates
• Pregnancy

Intervention

Drug:
• ganirelix
Daily 0.25 mg ganirelix administered to prevent premature LH surges during COS in order to achieve a pregnancy
• GnRH agonist
Long protocol of GnRH agonist administered to prevent premature LH surges during COS in order to achieve a pregnancy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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