Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)

NCT00702195 | Completed

• 2 other identifiers: P0605438817
• Study Type: observational
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this trial was to evaluate whether Org 36286 treatment in any Phase IIa clinical development trial of Org 36286 for OI or COH in assisted reproductive treatment programs was safe for pregnant subjects and their offspring. Data from subjects who participated in Trials 38805 and 38807 and became pregnant were evaluated.

Conditions

Pregnancy

Keywords

Neonatal outcome; Congenital malformations; In-Vitro Fertilization; Controlled ovarian stimulation; Follow-up; Ovulation Induction; Neonates

Outcome Measures

Primary Outcomes (1)

• Pregnancy status at 20 weeks of gestation; Take-home baby rate

  one pregnancy period

Secondary Outcomes (1)

• Pregnancy follow-up; Delivery follow-up; Neonatal outcome; Infant follow-up; Congenital Malformations and Chromosomal Abnormalities

  one pregnancy period

Study Arms (4)

Experimental Group 1

all doses of Org 36286 (corifollitropin alfa) from trial 38805 (7.5 μg, 15 μg, 30 μg and 60 μg)

Drug: Org 36286 (corifollitropin alfa)

Experimental Group 2

Placebo

Drug: Placebo

Experimental Group 3

all doses of Org 36286 (corifollitropin alfa) from trial 38807 (120 μg, 180 μg and 240 μg)

Drug: Org 36286 (corifollitropin alfa)

Experimental Group 4

150 IU Puregon®

Drug: recFSH

Interventions

Org 36286 (corifollitropin alfa) DRUG

single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807

Also known as: corifollitropin alfa

Experimental Group 1; Experimental Group 3

Placebo DRUG

single dose of placebo (administered under protocol 38805)

Experimental Group 2

recFSH DRUG

150 IU recFSH daily (reference group administered under protocol 38807)

Also known as: follitropin beta, Puregon®, Follistim®

Experimental Group 4

Eligibility Criteria

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

Study Population

All women who became pregnant during Trials 38805 or 38807 were enrolled in Trial 38817

You may qualify if:

• Subjects taking part in any clinical development trial of Org 36286 for OI or COH for IVF in Phase IIa;
• Ongoing pregnancy confirmed by ultrasonography (USS) at or beyond 12 weeks of gestation;
• Able and willing to give written informed consent.

You may not qualify if:

• None

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15.

  PMID: 22587997 DERIVED

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; follitropin beta

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

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

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 20, 2008
• Study Start: January 1, 2002
• Primary Completion: September 15, 2003
• Study Completion: September 15, 2003
• Last Updated: August 15, 2024

Record last verified: 2022-02