drugset / Trial / NCT02775734

NAC in CC Resistant PCOS After LOD

NCT02775734

Phase 2/3 Completed 144 enrolled Ain Shams University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This prospective randomized placebo-controlled double blind clinical trial will conducted in Ain Shams University maternity Hospital including 120 women diagnosed with clomiphene citrate resistant polycystic ovary syndrome. After laparoscopic ovarian drilling, they will be randomized to either receiving 50 mg oral clomiphene citrate twice daily and oral NAC 1,200 mg/day for 5 days starting from cycle day 2 to cycle day 6 (group 1 = 60 patients) or clomiphene citrate only (group 2 = 60 patients). The primary outcome will be biochemical pregnancy rate, secondary outcomes include Clinical pregnancy rate, ovulation rate, live birth rate, number of follicles ≥ 18 mm and endometrial thickness at triggering ovulation, mid- luteal sub-endometrial blood flow indices, and incidence of side effects.

Timeline

Start
2016-05
Primary completion
2017-03
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator N-acetylcysteine Small molecule 1200 mg Oral
Comparator Clomiphene Other / unclassified 50 mg Oral