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Gonadorelin

GnRH, Luteinizing Hormone-Releasing Hormone, LHRH, Factrel

Quick Stats
Studies 192
Trials 100
Completed PHASE3 INTERVENTIONAL NCT01185704

Analysis of Two Therapeutic With CetrotideĀ® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is a randomized open-label study to compare between in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of CetrotideĀ® (Cetrorelix acetate) which are 0.25 milligram (mg) used from Day 1 or Day 7 of the menstrual cycle (Day 0 or Day 6 of stimulation) in polycystic ovarian (PCO) women in assisted reproductive technology (ART).

Detailed Description

Polycystic ovarian syndrome population is an androgenic syndrome characterized by a wide spectrum of clinical manifestations such as obesity, hirsutism, insulin resistance, diabetes and presence of specific ultrasonic features. CetrotideĀ®, cetrorelix acetate, is an antagonist of luteinizing-hormone-releasing hormone (LHRH). CetrotideĀ® is registered in 70 countries (including France) for the prevention of premature ovulation in subjects undergoing a controlled ovarian stimulation, followed by oocyte pick-up and ARTs. OvitrelleĀ®, active ingredient human chorionic-gonadotropin alfa, is administered to trigger final follicular maturation and luteinization after stimulation of follicular growth. OBJECTIVES Primary objective: * To compare the hormonal level of plasmatic estradiol on the releasing day (day of r-hCG administration) induced by CetrotideĀ® 0.25 mg/day started on Day 1 (Group A: Day 1) or on Day 7 (Group B: Day 7) of the menstrual cycle (Day 0 (S0) or Day 6 (S6) of stimulation) in PCO subjects undergoing IVF/ICSI procedures. Secondary objectives: * To compare the hormonal changes during the stimulation induced by CetrotideĀ® in A and B Groups * To assess by ultrasound scans (US) the follicular development induced by CetrotideĀ® in A and B Groups * To assess biological and clinical outcomes induced by CetrotideĀ® in A and B Groups * To monitor safety of Cetrotide in A and B Groups The trial will be conducted on an outpatient basis. Once each subject has met all eligibility criteria, they will be randomly assigned in one of the two treatment groups.

Interventions

Name: Cetrorelix acetate
Type: DRUG
Description: CetrotideĀ® 0.25 mg will be administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) until r-hCG day (at least 2 follicles \>=17 mm)
Name: Cetrorelix acetate
Type: DRUG
Description: CetrotideĀ® 0.25 mg will be administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) until r-hCG day (at least 2 follicles \>=19 mm)
Name: Recombinant Human Choriogonadotropin (r-hCG)
Type: DRUG
Description: The r-hCG will be administered subcutaneously as a single dose of 250 microgram (mcg) on r-hCG day
Name: Recombinant human follicle stimulating hormone (r-hFSH)
Type: DRUG
Description: Recombinant human follicle stimulating hormone (r-hFSH) will be administered subcutaneously at a dose between 75 and 187.5 international unit (IU) once daily from Day 2 (Day 1 of stimulation period \[S1\]) until r-hCG day

Primary Outcomes

Measure: Estradiol (E2) Levels on r-hCG Day
TimeFrame: r-hCG day (end of stimulation cycle [approximately 15 days])
Description:

Trial Information

NCT ID

NCT01185704

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Merck KGaA, Darmstadt, Germany

Last Updated

December 15, 2025