Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)(P06056)(COMPLETED)

Pregnancy Clinical Trial

Official title:

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 for the Development of Org 36286 (Corifollitropin Alfa).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702988
• Other study ID #: P06056
• Secondary ID: 38827
• Status: Completed
• Start date: October 1, 2003
• Est. completion date: February 28, 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 objective of this trial was to evaluate whether Org 36286 treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant subjects and their offspring.

Description:

This was an open, prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during Trial 38826. For this trial, no study specific assessments were required, but information obtained in standard practice was used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 28, 2005
• Est. primary completion date: February 28, 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Subjects who participated in Trial 38826 and became pregnant (as confirmed by USS at or beyond 10 weeks after ET) after having received at least one dose of either Org 36286 or Puregon®; and

• Able and willing to give written informed consent.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Neonates
• Pregnancy

Intervention

Drug:
• Org 36286
single dose of 60, 120, or 180 µg Org 36286 (experimental group administered under protocol 38826)
• recFSH
150 IU recFSH daily (reference group administered under protocol 38826)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy status at 20 weeks of gestation		one pregnancy period
Primary	Take-home baby rate		one pregnancy period
Secondary	Pregnancy follow-up		one pregnancy period
Secondary	Delivery follow-up		one pregnancy period
Secondary	Neonatal outcome		one pregnancy period
Secondary	Infant follow-up		one pregnancy period
Secondary	Congenital malformations and chromosomal abnormalities		one pregnancy period