NCT03206892.
| Trial name or title | LESS surgery versus conventional multiport laparoscopy in ovarian drilling |
| Methods | Randomised controlled trial, parallel‐assignment |
| Participants | Inclusion criteria: Aged 16 to 50 years; PCOS according to Rotterdam Criteria (2 out of 3): polycystic ovaries (12 or more follicles in each ovary and/or increased ovarian volume > 10 cm3), oligo‐ or an‐ovulation, clinical and/or biochemical hyperandrogenism after exclusion of other aetiologies for irregular cycles. Indications of laparoscopic ovarian drilling: clomiphene citrate‐resistance or failure: failure to conceive after 6 to 9 cycles, other indications for laparoscopy; before gonadotropin administration to decrease risk of OHSS and multiple pregnancy; before ART to decrease risk of severe OHSS in women who previously had cancelled IVF cycles due to OHSS risk or who suffered from OHSS in a previous treatment. Exclusion criteria: Previous 2 or more laparotomies; chronic pelvic pain, endometriosis or pelvic inflammatory diseases to avoid pelvic adhesions and bias in the quantification of postoperative pain; high BMI (> 35kg/m2); do not possess a native umbilicus; advanced gynaecological surgeries or malignant disorders (total laparoscopic hysterectomy, laparoscopically assisted vaginal hysterectomy , laparoscopic myomectomy); contraindication to any laparoscopy‐like medical condition worsened by pneumoperitoneum or Trendelnburg position |
| Interventions | Laparoscopic ovarian drilling for PCOS in infertile women using laparo‐endoscopic single‐site surgery (LESS surgery: single incision through the umbilicus using modified Hasson technique), versus Conventional multi‐port laparoscopy LOD for PCOS |
| Outcomes | Primary outcome: successful surgical procedure Secondary outcome: operative time, intraoperative blood loss, intraoperative complications, postoperative hospital stay, postoperative pain, postoperative complications, cosmetic outcome |
| Starting date | August 2017 |
| Contact information | Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital, Egypt |
| Notes |