NCT00298025

A Study to Compare the Safety and Efficacy of Cetrotide® 3 Milligram (mg) Versus Antagon™ in Women Undergoing Ovarian Stimulation

A Phase IV, Multicenter, Open-label, Randomized Study to Compare the Safety and Efficacy of Cetrotide® 3 mg Versus Antagon™ in the Inhibition of a Premature LH Surge in a r-hFSH/hMG Stimulation Cycle With OCP Programming in Women Undergoing Ovarian Stimulation Prior to ART

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: EMD Serono · Industry
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the comparative safety and efficacy of Cetrotide® 3 milligram (mg) and Antagon™ in the inhibition of a premature luteinizing hormone (LH) surge in women undergoing ovarian stimulation with recombinant human follicle stimulating hormone/human menopausal gonadotropin (r-hFSH/hMG) prior to assisted reproductive technology (ART) and utilizing oral contraceptives pill (OCP) for cycle programming.

Conditions

• Infertile Women Undergoing Assisted Reproductive Technology (ART)

Interventions

Type	Name	Description
DRUG	Cetrotide®	Cetrotide® will be administered subcutaneously as 3 mg injection when the lead follicle is \>=14 mm till r-hCG day. If the subject did not achieve follicular maturation and did not receive r-hCG within 4 days, then the Cetrotide® will be administered at dose of 0.25 mg subcutaneously on successive days until r-hCG day.
DRUG	Antagon ™	Antagon™ will be administered subcutaneously at a dose of 0.25 mg once daily when the lead follicle is \>=14 mm until r-hCG day.
DRUG	Recombinant human follicle stimulating hormone (r-hFSH)	Recombinant human follicle stimulating hormone (r-hFSH) will be administered at a starting dose of 225 international unit (IU) subcutaneously once daily from S1 up to Stimulation Day 5 (S5). Beginning on Stimulation Day 6 (S6), the r-hFSH dose will be individualized to the subject. The minimum and maximum daily doses are 75 IU and 450 IU, respectively until r-hCG day.
DRUG	Human Menopausal Gonadotropin (hMG)	Human menopausal gonadotropin (hMG) will be administered subcutaneously daily at a dose of 75 IU till r-hCG day. The total daily dose of r-hFSH and hMG combined is not to exceed 450 IU (375 IU r-hFSH and 75 IU hMG).
DRUG	Recombinant Human Choriogonadotropin (r-hCG)	The r-hCG will be administered as a single dose of 250 microgram (mcg) subcutaneously when there is at least one follicle of \>=18 mm and two additional follicles of \>=16 mm with an appropriate plasma estradiol levels for the number and size of the existing follicles. The r-hCG will be administered within 36 hours after the last dose of the r-hFSH/hMG.

Timeline

• Start date: 2003-09-01
• Primary completion: 2004-05-01
• Completion: 2004-05-01
• First posted: 2006-03-01
• Last updated: 2014-03-26