An interventional study of ovarian drilling by abdominal Laparoscopy and Ovarian drilling by vaginal laparoscopy VNotes in PCOS (Polycystic Ovary Syndrome), sponsored by University Hospital, Clermont-Ferrand. Recruiting at 1 site in France. Open to female participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and 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.
Latest State of Scientific Knowledge Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder in young women (5% of women of reproductive age) and is responsible for 70% of anovulatory infertility cases.
Since 2003, it has been defined according to the College of Obstetricians and Gynecologists of France by the Rotterdam criteria, which were revised by ESHRE in 2023.
According to these criteria, to diagnose PCOS, it is necessary to present at least two of the following three criteria and to have excluded other diagnoses:
Menstrual cycle abnormalities (amenorrhea, oligomenorrhea, long cycles) Clinical (hirsutism, acne, hair loss) or biological hyperandrogenism (elevated levels of free and total testosterone) Presence of polycystic ovaries on ultrasound: at least 12 follicles measuring 2 to 9 mm in diameter in each ovary or more than 20 follicles regardless of size. The number of follicles is more relevant than ovarian volume .
PCOS is a significant concern for reproductive medicine as it is associated with 20% to 74% infertility due to arrested follicular maturation caused by a multifactorial mechanism, particularly involving hyperandrogenism caused by excessive androgen production by the ovarian theca cells.
Ovarian stimulation is the first-line treatment for infertility related to PCOS as there is no etiological treatment. The first-line treatment is Clomiphene Citrate. It is a SERM that acts by inhibiting the negative feedback of estrogens on FSH. In case of failure, second-line treatment is ovarian drilling or gonadotropin stimulation according to ESHRE 2018 recommendations. Ovarian drilling involves making perforations in the ovarian stroma to destroy approximately 5% of the cortex of each ovary. It is recommended to use bipolar energy rather than monopolar or CO2 laser energy to reduce the risk of adhesions. Moreover, bipolar energy decreases the diffusion of energy compared to monopolar, thus limiting the reduction of the ovarian follicle pool. Although the mechanism remains unclear, it appears that the destruction of ovarian stroma by microperforations reduces androgen levels, increases FSH levels, and promotes follicular maturation.
The first ovarian drilling by laparoscopy was described in 1984 by Gjonnaess and his team. It was traditionally performed via laparoscopy or fertiloscopy. The latter technique is no longer practiced due to the discontinuation of the device.
More recently, in the 2010s, a new minimally invasive laparoscopic technique, vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery), was developed, using a natural orifice: the vagina. This method was first developed in Taiwan in 2012, then in Belgium.
With the development of the vNOTES laparoscopic technique for benign gynecological pathologies, particularly adnexal pathologies, the question arises of a new approach for ovarian drilling. Indeed, data on its use in the context of ovarian drilling are very limited, but initial results show a minimally invasive approach with good access to the pelvic cavity, minimal scarring, and reduced postoperative pain . The ovarian drilling technique using vNOTES was recently described by Professor Fernandez and his team and presented in a video at the SCGP congress in 2022 .
Hypotheses and Objectives The study is based on the hypothesis that ovarian drilling via vaginal vNOTES laparoscopy is at least as effective as the conventional laparoscopic technique in terms of resumption of ovulatory cycles. The objective is to evaluate the effectiveness of vaginal vNOTES laparoscopy compared to abdominal laparoscopy for ovarian drilling in women with polycystic ovary syndrome undergoing medically assisted reproduction.
Summary of Expected Benefits and Risks for Participants Expected benefits for patients in the VNotes group: shorter operative duration, less significant pain evolution, and aesthetic benefits.
Risks: The risks are those associated with anesthesia and surgery: hemorrhage, infection, digestive, vascular, or urinary tract injury, vaginal scar dehiscence. The additional risks of laparoscopy are those associated with trocars: hemorrhage, infection, herniation, and scar dehiscence.
The additional risk of vNOTES is the inability to complete the procedure, requiring conversion to laparoscopy.
Expected Outcomes If the ovarian drilling technique via VNotes proves to be as effective as laparoscopy, it would legitimize the development of an innovative technique combining good anatomical visualization, absence of abdominal scarring, and better outcomes in the context of assisted reproduction, as well as improved postoperative recovery for patients, with equivalent results in terms of ovulation resumption and pregnancy.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's planned enrollment of 48 is below the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ovarian drilling procedure by abdominal laparoscopy 1st stage of surgery Patient in gynecological position, double skin cleansing with alcoholic Betadine and vaginal cleansing with dermal Betadine, placement of sterile drapes. Urinary evacuation catheterization. Introduction of a diagnostic hysteroscope via vaginoscopy. Progress through the cervical canal. Exploration of the uterine cavity. Cannulation using a manipulator to perform a tubal blue test. 2nd stage of surgery: Patient in supine position, legs slightly abducted and semi-flexed. Insufflation of pneumoperitoneum in left hypochondrium with Palmer needle after satisfactory syringe safety test, up to a pressure of 20 mmHg. Trans-umbilical coeliotomy allowing passage of a 10 mm optical trocar after infiltration of the tract with Naropein 7.5 mg/ml. Placement of two 5 mm operating trocars in the left iliac fossa and suprapubic area after infiltration of the tracts with Naropein 7.5 mg/ml. Single-stitch closure with Filapeau 3/0.
Procedure: ovarian drilling by abdominal Laparoscopy
Patient in gynecological position, double scrubbing of skin with alcoholic Betadine and vaginal with dermal Betadine, sterile drapes in place Urinary evacuation catheterization Introduction of a diagnostic hysteroscope via vaginoscopy Progress through the cervical canal Exploration of the uterine cavity Para-cervical block, uterine cannulation using a manipulator or a pediatric foley probe to perform a tubal blue test. Placement of a Pozzi on the posterior lip of the cervix. Vaginal incision 1 cm below the cervix for 2 cm, opening the peritoneum with scissors vNOTES Gelpoint device inserted Trendelenburg position Insufflation of pneumoperitoneum(8 mm Hg) Exploration of abdominal cavity Bilateral ovarian drilling; approx. 12 to 15 micro-perforations on each side using the bipolar Versapoint inserted in the Bettochi and regular saline instillation Systematic tubal blue test Removal of the device Exsufflation of pneumoperitoneum Closure of the cul de sac of Douglas with a MONOCRYL 2/0
Procedure: Ovarian drilling by vaginal laparoscopy VNotes
Ovarian drilling procedure by abdominal laparoscopy versus ovarian drilling procedure by laparoscopic Vnotes . see each arm for details for each intervention
Ovarian drilling by vaginal laparoscopy VNotes
The resumption (or not) of an ovulatory cycle
The resumption (or not) of an ovulatory cycle will be evaluated during the 6 months follow-up visit after the intervention. The resumption of cycles is defined by cycles lasting more than 3 months, an elevated progesterone level, or the presence of a corpus luteum on ultrasound."
Time frame: at the 6 months follow-up visit
Pain assessment
For each arm: Pain assessment using a VAS (Visual Analog Scale) requested from the patient in the recovery room at 1 hour during ambulatory care. The scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable
Time frame: 1 hour during ambulatory care
pain assessment
For each arm: Pain assessment using a VAS (Visual Analog Scale) requested from the patient in the recovery room at 6 hours during ambulatory care. The scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable
Time frame: 6 hours during ambulatory care
pain assessment
For each arm: Pain assessment using a VAS (Visual Analog Scale) requested from the patient through a questionnaire sent to the patients on Day 1 after the intervention. The scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable
Time frame: on day 1 after the intervention
pain assessment
For each arm: Pain assessment using a VAS (Visual Analog Scale) requested from the patient on Day 7 after the intervention. The scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable
Time frame: on day 7 after the intervention
pain assessment
For each arm: Pain assessment using a VAS (Visual Analog Scale) requested from the patient during the postoperative follow-up visit. The scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable
Time frame: at the postoperative follow-up visit (1 month)
The use of analgesics
For each arm: The use of analgesics (yes/no) recorded up to 2 hours postoperatively
Time frame: up to 2 hours postoperatively
The use of analgesics
For each arm: The use of analgesics (yes/no) recorded up to 24 hours postoperatively
Time frame: up to 24 hours postoperatively
The use of analgesics
For each arm: The use of analgesics (yes/no) recorded postoperatively through a questionnaire sent to the patients on Day 1.
Time frame: postoperatively on Day 1
The use of analgesics
For each arm: The use of analgesics (yes/no) recorded postoperatively through a questionnaire sent to the patients on day 7
Time frame: postoperatively on Day 7
The use of analgesics
For each arm: The use of analgesics (yes/no) recorded at the postoperative follow-up visit (1 month)
Time frame: at the postoperative follow-up visit (1 month)
The operative duration
For each arm: The operative duration from incision to closure recorded in the operating room, as well as the operative duration from the introduction of the Palmer needle in laparoscopy and the vaginal incision in VNotes until closure
Time frame: peroperatively
Rehospitalization due to complications
for each arm: Rehospitalization due to complications from the operation within the month following the procedure (yes/no), at the postoperative follow-up visit (1 month)
Time frame: at the postoperative follow-up visit (1 month)
Extension of the initial sick leave (yes/no)
For each arm: Extension of the initial sick leave (yes/no), assessed at the postoperative follow-up visit (1 month)
Time frame: at the postoperative follow-up visit (1 month)
The presence of intraoperative complications
for each arm: The presence of intraoperative complications recorded during the intervention according to the Clavien-Dindo classification, including whether a conversion occurred, and the number of such complications
Time frame: during the intervention
extension of the ambulatory stay (yes/no)
For each arm: The use of an extension of the ambulatory stay (yes/no) and the total duration of hospitalization in days and hours
Time frame: Upon discharge from hospitalization (assessed up to 5 days)
The occurrence of a pregnancy
The occurrence of a spontaneous pregnancy, IVF, twin pregnancy, or OHSS if IVF, assessed one year after the 6 months follow-up visit
Time frame: one year after the 6 months follow-up visit
The measurement of AMH
The measurement of AMH in nanograms/mL at the preoperative visit (1 month before the intervention)
Time frame: at the preoperative visit (1 month before the intervention)
The measurement of AMH
The measurement of AMH in nanograms/mL at the postoperative follow-up visit (1month).
Time frame: at the postoperative follow-up visit (1 month)
The measurement of AMH
The measurement of AMH in nanograms/mL at the Month 6 follow-up visit
Time frame: at the 6 Months follow-up visit
Satisfaction assessment
Satisfaction assessment through the SF-36 questionnaire at the postoperative follow-up visit
Time frame: at the postoperative follow-up visit (1 month)
Satisfaction assessment
Satisfaction assessment through the SF-36 questionnaire at the 6 Months follow-up visit
Time frame: at the 6 Months follow-up visit
Plan to share: No
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