Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS

Trial details

Who runs it

University Hospital, Clermont-Ferrand

Trial code

NCT07923552

Record updated

6 November 2026

Original description

Polycystic Ovary Syndrome (PCOS) is a common condition among young women (the leading endocrine disorder) and is responsible for 70% of anovulatory infertility cases. Clinically, it has been defined since 2003 by the Rotterdam criteria, according to the French College of Obstetricians and Gynecologists. PCOS represents a significant challenge in reproductive medicine, as it is associated with infertility rates ranging from 20% to 74%. Ovarian stimulation is the first-line treatment for PCOS, as no etiological treatment is available. The first-line pharmacological treatment is Clomiphene Citrate. In cases where Clomiphene Citrate fails, the second-line treatment is ovarian drilling. Traditionally, ovarian drilling was performed via laparoscopy or fertiloscopy. Fertiloscopy had the advantage of being quicker and scarless for patients, with reported failure and conversion rates to laparoscopy of 10% to 20% depending on the studies. However, fertiloscopy is no longer practiced due to the discontinuation of the device. With the advent of vNOTES laparoscopy (Vaginal Natural Orifice Transluminal Endoscopic Surgery) in the 2010s for benign gynecological conditions, the possibility of a new vaginal approach for ovarian drilling is now being considered. The Primary Objective is to Evaluate the efficacy of ovarian drilling via vNOTES laparoscopy in terms of resumption of spontaneous ovulatory cycles in PCOS patients requiring surgical treatment.Read full original descriptionShow less

Proof-of-Concept Study Evaluating the Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS Requiring Surgical Treatment.

Polycystic Ovary Syndrome (PCOS) is a common condition among young women (the leading endocrine disorder) and is responsible for 70% of anovulatory infertility cases. Clinically, it has been defined since 2003 by the Rotterdam criteria, according to the French College of Obstetricians and Gynecologists. PCOS represents a significant challenge in reproductive medicine, as it is associated with infertility rates ranging from 20% to 74%. Ovarian stimulation is the first-line treatment for PCOS, as no etiological treatment is available. The first-line pharmacological treatment is Clomiphene Citrate. In cases where Clomiphene Citrate fails, the second-line treatment is ovarian drilling. Traditionally, ovarian drilling was performed via laparoscopy or fertiloscopy. Fertiloscopy had the advantage of being quicker and scarless for patients, with reported failure and conversion rates to laparoscopy of 10% to 20% depending on the studies. However, fertiloscopy is no longer practiced due to the discontinuation of the device. With the advent of vNOTES laparoscopy (Vaginal Natural Orifice Transluminal Endoscopic Surgery) in the 2010s for benign gynecological conditions, the possibility of a new vaginal approach for ovarian drilling is now being considered. The Primary Objective is to Evaluate the efficacy of ovarian drilling via vNOTES laparoscopy in terms of resumption of spontaneous ovulatory cycles in PCOS patients requiring surgical treatment.

Study Type:

Single-center, randomized, controlled, two-arm, proof-of-concept study. Number of Centers: 1

Study Description:

During the gynecology consultation, if an indication for ovarian drilling is established, the patient will be invited to participate in the study protocol. The study information sheet, detailing the study procedures and objectives, along with the consent form, will be provided to the patient.

A second consultation with the investigator will be scheduled to address any questions following a reflection period. If the patient consents, both she and the investigator will sign the consent form.

Randomization will be conducted using REDCap® software. The patient will then be assigned to either the vNOTES group or the laparoscopy group. Surgery will be performed by surgeons designated as "experts" in the respective surgical approach. The procedure will follow the standard techniques of the department.

Ovulatory cycle resumption will be assessed 6 months postoperatively during a follow-up consultation.

Inclusion: 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: Need for another associated surgical procedure other than hysteroscopy (hysteroscopy, neostomy); Contraindication to either surgical approach (laparoscopy or vNOTES):; Any concomitant pathology deemed incompatible with the study; History of ovarian drilling; History of multiple pelvic surgeries; History of upper genital tract infection; History of rectal surgery; Current pregnancy or breastfeeding; Other infertility factors requiring IVF management; Confirmed or suspected recto-vaginal endometriosis on clinical examination; Promontofixation; Virgin patient; 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.

ClinicalTrials.gov NCT07923552