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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00378729
Acronym
PERCING
Enrollment
252
Registered
2006-09-21
Start date
2006-10-31
Completion date
2011-10-31
Last updated
2011-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

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

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%).

Interventions

DRUGMetformin and FSHr

treatment for infertility

PROCEDUREOvarian drilling by FERTILOSCOPY

surgical ovarian drilling

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-upduring 9 months of follow-up

Secondary

MeasureTime frame
Evaluation of toleranceduring the study
Occurrence of multiple pregnanciesat the end of the study
Duration of the menstrual cycles and hormonal ovarian dosagesduring the study
Occurrence of spontaneous miscarriagesat the end of the study
Body Mass Index with each visitat each visit

Countries

France

Contacts

Primary ContactHervé FERNANDEZ, MD,PhD
herve.fernandez@abc.aphp.fr+33(0)- 1 45 37 44 69

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026