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

NCT01185704 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2014-02-13

Study results available
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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 Cetrotide® (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).

Conditions

  • Polycystic Ovarian Syndrome

Interventions

DRUG

Cetrorelix acetate

Cetrotide® 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)

DRUG

Cetrorelix acetate

Cetrotide® 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)

DRUG

Recombinant Human Choriogonadotropin (r-hCG)

The r-hCG will be administered subcutaneously as a single dose of 250 microgram (mcg) on r-hCG day

DRUG

Recombinant human follicle stimulating hormone (r-hFSH)

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

Sponsors & Collaborators

  • Merck Serono S.A.S, France

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Dr Etienne VARLAN · Merck Lipha Santé

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-10-31
Completion
2012-02-29

Countries

  • France

Study Locations

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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 NCT01185704 on ClinicalTrials.gov