Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS

MI-összefoglaló

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The trial is looking for women with PCOS (polycystic ovary syndrome) and infertility who need ovarian drilling surgery. It compares surgery through the vagina (vNOTES) with standard abdominal laparoscopy.

Életkor

18 Years to 43 Years

Nem

Women only

A betegség stádiuma

PCOS defined by the Rotterdam criteria, with primary or secondary infertility, needing ovarian drilling.

Korábbi kezelés

First-line medical treatment must have failed. People who have had ovarian drilling before cannot join.

A részvétel fő kizáró okai

• Ovarian drilling in the past, or several past pelvic surgeries
• Being pregnant or breastfeeding now
• Other infertility causes that need IVF
• Past upper genital tract infection, rectal surgery, or confirmed or suspected recto-vaginal endometriosis
• Never having had sexual intercourse (virgin patient), or not speaking French

A regiszter feltételei, szó szerint

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

• 18 és 43 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 2 csoportja

• ovarian drilling by abdominal laparoscopyMár használt kezelés, összehasonlításként

  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.

• Ovarian drilling by vaginal laparoscopy VNotesA vizsgált kezelés

  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