NCT02381184.

Trial name or title	Extended CC regimen versus LOD for ovulation Induction in clomiphene‐resistant women With PCOS
Methods	Randomised controlled trial, parallel‐assignment.
Participants	Inclusion criteria: Aged 18 ‐ 35 years,> 2 years infertility, serum level of FSH < 10 U/L in the early follicular phase, CC‐resistant PCOS, as they failed to ovulate with a dose of CC of 150 mg/day for 5 days per cycle for at least 3 consecutive cycles. All women had patent fallopian tubes proved by hysterosalpingography or laparoscopy and their partners satisfied the normal parameters of semen analysis according to the modified WHO criteria Exclusion Criteria: Infertility due to causes other than CC‐ resistant PCOS or due to combined factors, BMI ≥ 35 Kg/m2, use of metformin, gonadotropins, hormonal contraception or diet regimen within the last 6 months; women with congenital adrenal hyperplasia, hyperprolactinaemia or abnormal thyroid function, hypersensitivity or contraindications to letrozole or clomiphene treatment; previous LOD
Interventions	CC 100 mg daily for 10 days starting on day 3 of cycle, versus LOD
Outcomes	Primary outcome measures: ovulation rate Secondary outcome measures: endometrial thickness, rates of clinical pregnancy
Starting date	June 2014
Contact information	Khalid Abd Aziz Mohamed, Benha University, Egypt
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