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Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovaries Syndrome (PCOS)

NCT00378729 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2011-10-04

No results posted yet for this study

Summary

PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies.

The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Metformin and FSHr

treatment for infertility

PROCEDURE

Ovarian drilling by FERTILOSCOPY

surgical ovarian drilling

Sponsors & Collaborators

  • Hopital Antoine Beclere

    collaborator OTHER

  • Hôpital Jean Verdier

    collaborator OTHER

  • Jean Rostand Intercommoned Hospital

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire, Amiens

    collaborator OTHER

  • University Hospital, Caen

    collaborator OTHER

  • University Hospital, Clermont-Ferrand

    collaborator OTHER

  • Lille Hospital : Jeanne de Flandre Hospital

    collaborator UNKNOWN

  • University Hospital, Strasbourg, France

    collaborator OTHER

  • CMCO SIHCUS, Schiltingheim

    collaborator OTHER

  • Study and research center of sterility (Lyon)

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Hervé FERNANDEZ, MD,PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2011-10-31
Completion
2011-10-31

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 NCT00378729 on ClinicalTrials.gov