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

NCT00298025 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2014-03-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Eduardo Kelly, MD, MBA · EMD Serono

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2004-05-31
Completion
2004-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00298025 on ClinicalTrials.gov