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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hopital Antoine Beclere
Jean Verdier Hospital (AP-HP)
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
SIHCUS-CMCO (Schiltigheim)
Study and research center of sterility (Lyon)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00378729
First received: September 19, 2006
Last updated: October 3, 2011
Last verified: October 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Polycystic Ovary Syndrome
 Drug: Metformin and FSHr
Procedure: Ovarian drilling by FERTILOSCOPY
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of tolerance [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • Occurrence of multiple pregnancies [ Time Frame: at the end of the study ] [ Designated as safety issue: Yes ]
  • Duration of the menstrual cycles and hormonal ovarian dosages [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • Occurrence of spontaneous miscarriages [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • Body Mass Index with each visit [ Time Frame: at each visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 252
Study Start Date: October 2006
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Metformin and FSHr
treatment for infertility
Other Name: treatment for infertility
Active Comparator: B Procedure: Ovarian drilling by FERTILOSCOPY
surgical ovarian drilling
Other Name: surgical ovarian drilling

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%).

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378729

Contacts
Contact: Hervé FERNANDEZ, MD,PhD +33(0)- 1 45 37 44 69 herve.fernandez@abc.aphp.fr

Locations
France
Hopital Antoine Beclere Recruiting
Clamart, France, 92170
Contact: Hervé FERNANDES, MD,PhD     +33(0)- 1 45 37 44 69     herve.fernandez@abc.aphp.fr    
Principal Investigator: Hervé FERNANDEZ, MD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Hopital Antoine Beclere
Jean Verdier Hospital (AP-HP)
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
SIHCUS-CMCO (Schiltigheim)
Study and research center of sterility (Lyon)
Investigators
Principal Investigator: Hervé FERNANDEZ, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00378729     History of Changes
Other Study ID Numbers: P051008
Study First Received: September 19, 2006
Last Updated: October 3, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
PCOS
FERTILOSCOPY
Ovarian hyperstimulation
Multiple pregnancies
Patient with PCOS (Rotterdam criteria)
 Failure of treatment with Clomiphene Citrate
Age between 18 and 36 years old
Spermogram must be normal
Permeability of Fallopian tubes

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013