NCT03664050.
Trial name or title | LOD versus letrozole In clomiphene‐resistant polycystic ovary |
Methods | Randomised controlled trial |
Participants | Inclusion criteria: diagnosed as PCOS according to Roterdam (2003) criteria; clomiphene‐resistance, i.e. failure to ovulate following 100 mg CC for 5 days for at least 3 cycles; patent fallopian tubes, confirmed by hysterosalpingography or hysteroscopic diagnosis; normal semen analysis parameters of the spouse according to the modified criteria of the World Health Organization; normal serum prolactin, thyroid stimulating hormone and 17‐OH progesterone; no systemic disease; no gonadotropin or other hormonal drug treatment during the preceding 3 months Exclusion criteria: Infertility induced by reasons other than PCOS; uterine cavity lesions or ovarian cyst; > 40 years old; BMI > 26 kg/m2; contraindications to general anaesthesia; history of pelvic surgery; other endocrine diseases; a history of liver or kidney disease |
Interventions | 2.5 mg letrozole oral tablets on the 2nd ‐ 3rd day of menses and then every day for 5 days. Treatment to be repeated for up to 3 cycles if the participant failed to conceive, versus Bilateral LOD: each ovary will be cauterised at 4 points, each for 4 sec at 40 W, at a depth of 7 ‐ 8 mm and a diameter of 3 ‐ 5 mm, using a monopolar electrosurgical needle according to the size of each ovary |
Outcomes | Primary outcome: ovulation rate Secondary outcomes: biochemical pregnancy rate, clinical pregnancy rate |
Starting date | September 2018 |
Contact information | Ahmed Abdelshafy, Ain shams university maternity hospital, Cairo, Egypt |
Notes |