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

Tracking Information

First Received Date ^ICMJE

September 19, 2006

Last Updated Date

October 3, 2011

Start Date ^ICMJE

October 2006

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

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 ]

Original Secondary Outcome Measures ^ICMJE

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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

Recruiting

Estimated Enrollment ^ICMJE

252

Estimated Completion Date

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

Gender

Female

Ages

18 Years to 36 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Hervé FERNANDEZ, MD,PhD

+33(0)- 1 45 37 44 69

herve.fernandez@abc.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00378729

Other Study ID Numbers ^ICMJE

P051008

Has Data Monitoring Committee

Yes

Responsible Party

Assistance Publique - Hôpitaux de Paris

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

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 ^ICMJE

Principal Investigator:

Hervé FERNANDEZ, MD,PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

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

To Top