NCT02775734.
Trial name or title | N‐acetyl‐cysteine in clomiphene‐resistant PCOS after LOD: a randomised controlled trial |
Methods | Randomised controlled trial, parallel‐assignment |
Participants | Inclusion criteria: Aged 18 to 35 years; BMI between 25 and 30 Kg/m2; CC‐resistant PCOS Exclusion criteria: BMI < 25 or > 30 Kg/m2, hyper‐ or hypothyroidism, or hyperprolactinaemia; current or previous (within the last 6 months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti‐obesity drugs or other hormonal drugs; intention to start a diet or a specific programme of physical activity; organic pelvic diseases; tubal or male‐factor infertility; interval of earlier treatment with any of the fertility drugs of < 6 months; contraindication to clomiphene citrate; liver disease, undiagnosed abnormal uterine bleeding, uterine fibroids, endometrial cancer, ovarian enlargement or OHSS or HCG injection: ovarian enlargement or hyper stimulation |
Interventions | LOD + N‐acetyl‐cysteine + CC, versus LOD + CC |
Outcomes | Primary outcome measures: Biochemical pregnancy rate Secondary outcome measures: Clinical pregnancy rate, live birth rate, ovulation rate, follicles ≥ 18 mm, pre‐ovulatory endometrial thickness, mid‐luteal sub‐endometrial doppler blood flow indices, incidence of side effects |
Starting date | May 2016 |
Contact information | Mohamed S Sweed, Ain Shams University, Cairo, Egypt |
Notes |