NCT00696800·Phase 3·INTERVENTIONAL

A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)

Ganirelix Other Completed

Status

Completed

Phase

Phase 3

Enrollment

1,509

Locations

Results

Posted

Publications

Study summary

What the protocol is testing.

To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of Corifollitropin Alfa is non-inferior to daily treatment with recFSH in initiating multifollicular growth.

Full detailed description

This is a randomized, double-blind, active-controlled, non-inferiority clinical trial investigating the efficacy and safety of a new treatment regimen with Corifollitropin Alfa, a recombinant gonadotropin applied to initiate and sustain follicular stimulation in controlled ovarian stimulation for Assisted Reproductive Technology (ART). For this regimen, participants receive a single injection of Corifollitropin Alfa and one week later, treatment is continued with daily recFSH up to the day of triggering final oocyte maturation. In the reference group participants receive daily injections of recFSH up to the day of triggering final oocyte maturation. Non-inferiority in ongoing pregnancy rates (assessed at least 10 weeks after embryo transfer) will be the primary endpoint for this trial. The number of oocytes retrieved will be analyzed as co-primary endpoint.

Interventions

Treatment arms and agents.

DRUG

Corifollitropin alfa

On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.

BIOLOGICAL

RecFSH / Follitropin beta (Days 1 to 7)

Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

DRUG

Placebo Corifollitropin alfa

Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.

DRUG

Placebo RecFSH / follitropin beta

Identical ready-for-use solution, but without the active ingedient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

BIOLOGICAL

RecFSH / Follitropin beta (Days 8 to hCG)

From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.

DRUG

Ganirelix

On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG

BIOLOGICAL

hCG

When 3 follicles \>= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP

BIOLOGICAL

Progesterone

On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.

Timeline

From registration to results.

First posted
Jun 13, 2008
Study start
Jun 27, 2006
Primary completion
Nov 19, 2007
Study completion
Jan 15, 2008
Results posted
Aug 21, 2014
Registry updated
Jun 20, 2024

Outcomes

What the study measures.

Primary outcomes

Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)

Time frame · Assessed at least 10 weeks after embryo transfer (up to 1 year)

An ongoing pregnancy is a fetus with heart activity at least 10 weeks after embryo transfer as assessed by Ultrasound Scan (USS) or Doppler or is confirmed by live birth. The ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy after embryo transfer, divided by the total number of participants who started treatment. Calculations were made per attempt, meaning that participants who did not have embryo transfers were considered not pregnant.

Mean Number of Oocytes Retrieved

Time frame · Up to 36 hours after administration of hCG (up to 1 year)

Up to 36 hours after receiving hCG, cumulus-oocyte-complexes were retrieved. Mean numbers retrieved were calculated per attempt, meaning that if a participant did not reach this stage in In Vitro Fertilization (IVF) treatment, zero values were imputed.

Secondary outcomes

Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1

Time frame · From Day 1 to day of hCG treatment (up to 1 year)

The amount of recFSH administered for a participant to reach 3 follicles \>= 17 mm, starting from treatment Day 1 onwards.

Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8

Time frame · From Day 8 to Day of hCG treatment (up to 1 year)

The amount of recFSH administered for a participant to reach 3 follicles \>= 17 mm, starting from treatment Day 8 onwards.

Serum FSH Levels During Stimulation