NCT07923552 Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
| NCT ID | NCT07923552 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | PCOS (Polycystic Ovary Syndrome) |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-03-14 |
| Primary Completion | 2030-09-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2025-03-14 with a primary completion date of 2030-09-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Anne-Sophie Gremeau
PRINCIPAL INVESTIGATOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT07923552 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 43 Years, studying PCOS (Polycystic Ovary Syndrome). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07923552 currently recruiting?
Yes, NCT07923552 is actively recruiting participants. Contact the research team at promo_interne_drci@chu-clermontferrand.fr for enrollment information.
Where is the NCT07923552 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France.
Who is sponsoring the NCT07923552 clinical trial?
NCT07923552 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Anne-Sophie Gremeau at University Hospital, Clermont-Ferrand. The trial plans to enroll 48 participants.