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

Polycystic Ovary Syndrome Clinical Trial

— PERCING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00378729
• Other study ID #: P051008
• Status: Recruiting
• Phase: Phase 4
• First received: September 19, 2006
• Last updated: October 3, 2011
• Start date: October 2006
• Est. completion date: October 2011

Study information

• Verified date: October 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Hervé FERNANDEZ, MD,PhD
• Phone: +33(0)- 1 45 37 44 69
• Email: herve.fernandez[@]abc.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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%).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin and FSHr
treatment for infertility

Procedure:
• Ovarian drilling by FERTILOSCOPY
surgical ovarian drilling

Locations

Country	Name	City	State
France	Hopital Antoine Beclere	Clamart

Sponsors (11)

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

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up		during 9 months of follow-up	Yes
Secondary	Evaluation of tolerance		during the study	Yes
Secondary	Occurrence of multiple pregnancies		at the end of the study	Yes
Secondary	Duration of the menstrual cycles and hormonal ovarian dosages		during the study	No
Secondary	Occurrence of spontaneous miscarriages		at the end of the study	No
Secondary	Body Mass Index with each visit		at each visit	No