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

October 3, 2011 updated by: Assistance Publique - Hôpitaux de Paris

PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 Ovarian drilling will be performed by FERTILOSCOPY. 126 patients will be necessary in each group (with interval of equivalence : 10%).

Study Type

Interventional

Enrollment (Anticipated)

252

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clamart, France, 92170
        • Recruiting
        • Hopital Antoine Beclere
        • Contact:
        • Principal Investigator:
          • Hervé FERNANDEZ, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 32 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age between 18 and 36 years old
  • Female patient with PCOS (Rotterdam criteria)
  • Failure of treatment with Clomiphene Citrate
  • Informed consent
  • Female patient with medical assurance
  • Patient in failure with PCOS and Clomiphene citrate

Exclusion Criteria:

  • Female patient is over 36 years old
  • Thyroid disease (4<TSH<0.3 mUI/L)
  • Virilizing tumor
  • FERTILOSCOPY non possible (Douglas cul de sac clinically fixed)
  • Anormality of SPERMOGRAM (abnormal time of migration of survival)
  • Prolactin > 1.5 N
  • Anormality of 17-OH Progesterone (<2 ng/mL)
  • Fallopian tubes non permeable TMS< 5 Millions
  • Female patient participant or have been participated to another clinical trial during the last month before the inclusion
  • Female patient without medical assurance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: Metformin and FSHr
treatment for infertility
Other Names:
  • treatment for infertility
Active Comparator: B
Procedure: Ovarian drilling by FERTILOSCOPY
surgical ovarian drilling
Other Names:
  • surgical ovarian drilling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up
Time Frame: during 9 months of follow-up
during 9 months of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of tolerance
Time Frame: during the study
during the study
Occurrence of multiple pregnancies
Time Frame: at the end of the study
at the end of the study
Duration of the menstrual cycles and hormonal ovarian dosages
Time Frame: during the study
during the study
Occurrence of spontaneous miscarriages
Time Frame: at the end of the study
at the end of the study
Body Mass Index with each visit
Time Frame: at each visit
at each visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

University Hospital, Strasbourg, France
Centre Hospitalier Universitaire, Amiens
University Hospital, Clermont-Ferrand
University Hospital, Caen
Hopital Antoine Beclere
CMCO SIHCUS, Schiltingheim
Hôpital Jean Verdier
Jean Rostand Intercommoned Hospital
Lille Hospital : Jeanne de Flandre Hospital
Study and research center of sterility (Lyon)

Investigators

  • Principal Investigator: Hervé FERNANDEZ, MD,PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

October 1, 2011

Study Registration Dates

First Submitted

September 19, 2006

First Submitted That Met QC Criteria

September 19, 2006

First Posted (Estimate)

September 21, 2006

Study Record Updates

Last Update Posted (Estimate)

October 4, 2011

Last Update Submitted That Met QC Criteria

October 3, 2011

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P051008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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