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EXpression PRofile Endometrium Samples Study

NCT01210144 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2013-12-27

Study results available
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Summary

This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f®. Physicians are interested in identifying predictive genetic markers in assisted reproductive technologies (ART) in addition to the clinical predictive factors already known. Among those predictive factors, the state of the endometrium is considered as an important implantation determining factor for which pharmacogenomic research is of great interest.

The direct benefits of this study will be to know whether the endometrial gene expression profile is modified in response to stimulation treatment and have an impact or not on the endometrial tissue receptivity. The potential benefits of this study could be to assess the therapy optimization based on individual treatment response and gene expression profile compared to group treatment response in infertile women and prediction of response to therapy based on gene expression profiling before and after Gonal-f® stimulation in infertile women.

Conditions

  • In Vitro Fertilization

Interventions

DRUG

Gonal -f® [r-hFSH]

On Day 2 of the menstrual cycle, a pre-defined fixed dose of 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH) will be administered until follicles are recruited and developed.

DRUG

Ovitrelle® [r-hCG alfa]

Ovulation triggering will be performed using a single injection of 250 microgram (mcg) recombinant human chorionic gonadotropin (r-hCG) alfa as soon as follicles satisfy the criteria for follicular development, that is at least 3 follicles greater than (\>) 16 millimeter (mm), and with estradiol (E2) \> 1 microgram per liter (mcg/L) if gonadotropin releasing hormone (GnRH) agonist will be used.

DRUG

Gonadotropin-releasing hormone (GnRH) Agonist

To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily will be given after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.

DRUG

Gonadotropin-releasing hormone (GnRH) Antagonist

To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily will be given from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.

Sponsors & Collaborators

  • Merck Serono S.A.S, France

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

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
2008-08-31
Primary Completion
2010-08-31
Completion
2010-08-31

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 NCT01210144 on ClinicalTrials.gov