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

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ClinicalTrials.gov Identifier: NCT00378729
Recruitment Status : Unknown
Verified October 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : September 21, 2006
Last Update Posted : October 4, 2011
Sponsor:
Collaborators:
Hopital Antoine Beclere
Hôpital Jean Verdier
Jean Rostand Intercommoned Hospital
Centre Hospitalier Universitaire, Amiens
University Hospital, Caen
University Hospital, Clermont-Ferrand
Lille Hospital : Jeanne de Flandre Hospital
Strasbourg Hospital : Civil Hospital
CMCO SIHCUS, Schiltingheim
Study and research center of sterility (Lyon)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE September 19, 2006
First Posted Date  ICMJE September 21, 2006
Last Update Posted Date October 4, 2011
Study Start Date  ICMJE October 2006
Estimated Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2006)
Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up
Change History Complete list of historical versions of study NCT00378729 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2007)
  • Evaluation of tolerance [ Time Frame: during the study ]
  • Occurrence of multiple pregnancies [ Time Frame: at the end of the study ]
  • Duration of the menstrual cycles and hormonal ovarian dosages [ Time Frame: during the study ]
  • Occurrence of spontaneous miscarriages [ Time Frame: at the end of the study ]
  • Body Mass Index with each visit [ Time Frame: at each visit ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2006)
  • Evaluation of tolerance
  • Occurrence of multiple pregnancies
  • Duration of the menstrual cycles and hormonal ovarian dosages
  • Occurrence of spontaneous miscarriages
  • Body Mass Index with each visit
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovaries Syndrome (PCOS)
Official Title  ICMJE PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment
Brief 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

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • Drug: Metformin and FSHr
    treatment for infertility
    Other Name: treatment for infertility
  • Procedure: Ovarian drilling by FERTILOSCOPY
    surgical ovarian drilling
    Other Name: surgical ovarian drilling
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: Metformin and FSHr
  • Active Comparator: B
    Intervention: Procedure: Ovarian drilling by FERTILOSCOPY
Publications * Fernandez H, Watrelot A, Alby JD, Kadoch J, Gervaise A, deTayrac R, Frydman R. Fertility after ovarian drilling by transvaginal fertiloscopy for treatment of polycystic ovary syndrome. J Am Assoc Gynecol Laparosc. 2004 Aug;11(3):374-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 19, 2006)
252
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2011
Estimated Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 36 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00378729
Other Study ID Numbers  ICMJE P051008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE
  • Hopital Antoine Beclere
  • Hôpital Jean Verdier
  • Jean Rostand Intercommoned Hospital
  • Centre Hospitalier Universitaire, Amiens
  • University Hospital, Caen
  • University Hospital, Clermont-Ferrand
  • Lille Hospital : Jeanne de Flandre Hospital
  • Strasbourg Hospital : Civil Hospital
  • CMCO SIHCUS, Schiltingheim
  • Study and research center of sterility (Lyon)
Investigators  ICMJE
Principal Investigator: Hervé FERNANDEZ, MD,PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP