Ovarian drilling via vNOTES laparoscopy for PCOS patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates ovarian drilling performed with vNOTES laparoscopy as a second-line option for women with PCOS and infertility after failure of initial medical therapy. Participants have PCOS diagnosed by Rotterdam criteria and are seeking fertility treatment, including those with primary or secondary infertility. The procedure compares a vaginally guided, scar-minimizing approach to traditional abdominal laparoscopy, focusing on feasibility and safety. Eligible patients must meet criteria, consent, and not have prior ovarian drilling or other exclusionary conditions. The trial is conducted at CHU Clermont-Ferrand under the lead sponsor University Hospital, Clermont-Ferrand.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* PCOS defined by Rotterdam criteria requiring ovarian drilling after failure of first-line medical treatment
* Primary or secondary infertility
* Able to provide informed consent to participate in the research

Exclusion Criteria:

* History of ovarian drilling
* History of multiple pelvic surgeries
* Current pregnancy or breastfeeding
* Need for another associated surgical procedure other than hysteroscopy (hysteroscopy, neostomy)
* Other infertility factors requiring IVF management
* Contraindication to either surgical approach (laparoscopy or vNOTES):
* History of upper genital tract infection
* Confirmed or suspected recto-vaginal endometriosis on clinical examination
* History of rectal surgery
* Promontofixation
* Virgin patient
* Any concomitant pathology deemed incompatible with the study
* Patients not affiliated with the social security system
* Patients not speaking French
* Patients under guardianship, curatorship, deprived of liberty, or under judicial protection
* Refusal to participate

Where it's running

• CHU Clermont-Ferrand
  Clermont-Ferrand, France Recruiting

Study contacts

• Principal investigator: Anne-Sophie Gremeau — University Hospital, Clermont-Ferrand
• Study coordinator: Lise Laclautre
• Email: promo_interne_drci@chu-clermontferrand.fr
• Phone: +33473754963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.