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NAC in CC Resistant PCOS After LOD

NCT02775734 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2017-05-02

No results posted yet for this study

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.

Conditions

  • Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Interventions

DRUG

N-acetyl-cysteine

N-acetyl-cysteine + Clomiphene citrate + Laparoscopic ovarian drilling

DRUG

Clomiphene citrate

Clomiphene citrate + Laparoscopic ovarian drilling

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02775734 on ClinicalTrials.gov