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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:
Information provided by (Responsible Party):

Study Description
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


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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2006
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Evaluation of tolerance [ Time Frame: during the study ]
  2. Occurrence of multiple pregnancies [ Time Frame: at the end of the study ]
  3. Duration of the menstrual cycles and hormonal ovarian dosages [ Time Frame: during the study ]
  4. Occurrence of spontaneous miscarriages [ Time Frame: at the end of the study ]
  5. Body Mass Index with each visit [ Time Frame: at each visit ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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
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
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: October 4, 2011
Last Verified: October 2007

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:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs