Brief Summary

The objective of this trial is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) is safe for pregnant participants and their offspring. In addition, a primary efficacy variable, live birth rate, was evaluated.

Trial Health

100

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

268

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Feb 2007

Typical duration for all trials

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

February 15, 2007

Completed

1.3 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2009

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2010

Completed

5.3 years until next milestone

Results Posted

Study results publicly available

April 27, 2015

Completed

Last Updated

September 5, 2024

Status Verified

February 1, 2022

Enrollment Period

2.7 years

First QC Date

June 18, 2008

Results QC Date

April 9, 2015

Last Update Submit

August 13, 2024

Conditions

Pregnancy Neonates

Keywords

Neonatal outcomeCongenital malformationsIn-Vitro fertilizationControlled ovarian stimulationFollow-up

Outcome Measures

Primary Outcomes (5)

Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate)
The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants.
Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)
Number of Expectant Mothers Experiencing Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)
Number of Expectant Mothers Experiencing Serious AEs (SAEs)
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)
Number of Live Born Infants Experiencing AEs
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Up to 12 weeks after birth
Number of Live Born Infants Experiencing SAEs
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Up to 12 weeks after birth

Study Arms (1)

Women/Expectant Mothers - Corifollitropin Alfa 150 µg

In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin (\[rec\]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh embryo transfer in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.

Biological: Corifollitropin alfaBiological: GnRH antagonistBiological: (rec)hCGBiological: FSHDrug: Progesterone

Interventions

Corifollitropin alfaBIOLOGICAL

Subcutaneous (SC) administration of corifollitropin alfa at a dose of 150 μg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.

Also known as: Org 36286, SCH 900962, MK-8962