PCOS (Polycystic Ovary Syndrome)DRINOTESNCT07923552
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
A study testing ovarian drilling by abdominal Laparoscopy and Ovarian drilling by vaginal laparoscopy VNotes in people with PCOS (Polycystic Ovary Syndrome), run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- ovarian drilling by abdominal Laparoscopy and Ovarian drilling by vaginal laparoscopy VNotes
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2025to 14 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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):
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Aurélie Comptour, PhD, +33679146776, acomptour@chu-clermontferrand.fr
Aurélie Jacobs, PhD, ajacobs@chu-clermontferrand.fr
About this study
Official title: 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:
Read more
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.
Read the detailed description
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.
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- ovarian drilling by abdominal Laparoscopy, Ovarian drilling by vaginal laparoscopy VNotes
- Keywords
- PCOS, drilling, Vnotes, laparoscopy
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ovarian drilling by abdominal LaparoscopyProcedure or surgery
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 VNotesProcedure or surgery
Ovarian drilling by vaginal laparoscopy VNotes
| Study group | Role | What they receive |
|---|---|---|
| ovarian drilling by abdominal laparoscopy | Active comparator | 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. Receives: Procedure: ovarian drilling by abdominal Laparoscopy |
| Ovarian drilling by vaginal laparoscopy VNotes | Experimental | 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 Receives: Procedure: Ovarian drilling by vaginal laparoscopy VNotes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: at the 6 months follow-up visit
Secondary outcomes (21)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 2 hours postoperatively
The use of analgesics
For each arm: The use of analgesics (yes/no) recorded up to 24 hours postoperatively
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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
Measured: at the 6 Months follow-up visit
Satisfaction assessment
Satisfaction assessment through the SF-36 questionnaire at the postoperative follow-up visit
Measured: at the postoperative follow-up visit (1 month)
Satisfaction assessment
Satisfaction assessment through the SF-36 questionnaire at the 6 Months follow-up visit
Measured: at the 6 Months follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start14 Mar 2025
- Primary completion14 Sep 2030 (estimated)
- Study completion14 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Sophie Gremeau, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923552
- Sponsor's protocol ID
- RBHP 2024 GREMEAU 2
- Other IDs
- 2024-A01773-44
- Acronym
- DRINOTES
- Status last verified
- Apr 2026
- First submitted
- 19 Sep 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098.
PubMed 14688154Torre A, Fernandez H. [Polycystic ovary syndrome (PCOS)]. J Gynecol Obstet Biol Reprod (Paris). 2007 Sep;36(5):423-46. doi: 10.1016/j.jgyn.2007.04.002. Epub 2007 May 30. French.
PubMed 17540511
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-Concept Study Evaluating the Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS Requiring Surgical Treatment.
- ClinicalTrials.gov ID
- NCT07923552
- Acronym / sponsor ID
- DRINOTES / RBHP 2024 GREMEAU 2
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Keywords
- PCOS, drilling, Vnotes, laparoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 14 Sep 2030 (estimated)
- Study completion
- 14 Sep 2030 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ovarian drilling by abdominal laparoscopy | Active comparator | Procedure: ovarian drilling by abdominal LaparoscopyOvarian 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. |
| Ovarian drilling by vaginal laparoscopy VNotes | Experimental | Procedure: Ovarian drilling by vaginal laparoscopy VNotesPatient 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 |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ovarian drilling by abdominal LaparoscopyOvarian drilling procedure by abdominal laparoscopy versus ovarian drilling procedure by laparoscopic Vnotes . see each arm for details for each intervention | Procedure or surgery | ovarian drilling by abdominal laparoscopy |
| Ovarian drilling by vaginal laparoscopy VNotesOvarian drilling by vaginal laparoscopy VNotes | Procedure or surgery | Ovarian drilling by vaginal laparoscopy VNotes |
Primary outcome
The resumption (or not) of an ovulatory cycle
Time frame: at the 6 months follow-up visit
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."
21 secondary outcomes
Pain assessment
Time frame: 1 hour during ambulatory care
pain assessment
Time frame: 6 hours during ambulatory care
pain assessment
Time frame: on day 1 after the intervention
pain assessment
Time frame: on day 7 after the intervention
pain assessment
Time frame: at the postoperative follow-up visit (1 month)
The use of analgesics
Time frame: up to 2 hours postoperatively
The use of analgesics
Time frame: up to 24 hours postoperatively
The use of analgesics
Time frame: postoperatively on Day 1
The use of analgesics
Time frame: postoperatively on Day 7
The use of analgesics
Time frame: at the postoperative follow-up visit (1 month)
The operative duration
Time frame: peroperatively
Rehospitalization due to complications
Time frame: at the postoperative follow-up visit (1 month)
Extension of the initial sick leave (yes/no)
Time frame: at the postoperative follow-up visit (1 month)
The presence of intraoperative complications
Time frame: during the intervention
extension of the ambulatory stay (yes/no)
Time frame: Upon discharge from hospitalization (assessed up to 5 days)
The occurrence of a pregnancy
Time frame: one year after the 6 months follow-up visit
The measurement of AMH
Time frame: at the preoperative visit (1 month before the intervention)
The measurement of AMH
Time frame: at the postoperative follow-up visit (1 month)
The measurement of AMH
Time frame: at the 6 Months follow-up visit
Satisfaction assessment
Time frame: at the postoperative follow-up visit (1 month)
Satisfaction assessment
Time frame: at the 6 Months follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 14688154Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098.
- Background: PubMed 17540511Torre A, Fernandez H. [Polycystic ovary syndrome (PCOS)]. J Gynecol Obstet Biol Reprod (Paris). 2007 Sep;36(5):423-46. doi: 10.1016/j.jgyn.2007.04.002. Epub 2007 May 30. French.
- Individual participant dataSharing planned: No
Related trials for PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne-Sophie Gremeau principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ovarian drilling by abdominal Laparoscopy and Ovarian drilling by vaginal laparoscopy VNotes in people with PCOS (Polycystic Ovary Syndrome), run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The resumption (or not) of an ovulatory cycle (time frame: at the 6 months follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07923552, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.