NAC in CC Resistant PCOS After LOD

Overview

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.

Full Title of Study: “N-acetyl-cysteine in Clomiphene Citrate Resistant Polycystic Ovary Syndrome After Laparoscopic Ovarian Drilling: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2017

Interventions

  • Drug: N-acetyl-cysteine
    • N-acetyl-cysteine + Clomiphene citrate + Laparoscopic ovarian drilling
  • Drug: Clomiphene citrate
    • Clomiphene citrate + Laparoscopic ovarian drilling

Arms, Groups and Cohorts

  • Active Comparator: N-acetyl-cysteine
    • N-acetyl-cysteine + Clomiphene citrate + LOD
  • Active Comparator: NO N-acetyl-cysteine
    • Clomiphene citrate + LOD

Clinical Trial Outcome Measures

Primary Measures

  • Biochemical pregnancy rate
    • Time Frame: 6 months

Secondary Measures

  • Clinical pregnancy rate
    • Time Frame: 6 months
  • Live-birth rate
    • Time Frame: 15 months
  • Ovulation rate
    • Time Frame: 6 months
  • follicles more than or equal 18 mm
    • Time Frame: 6 months
  • Pre-ovulatory endometrial thickness
    • Time Frame: 6 months
  • mid-luteal sub-endometrial doppler blood flow indices
    • Time Frame: 6 months
  • Incidence of side effects
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • Body mass index (BMI) between 25 and 30 Kg/m 2. – CC-resistant Polycystic ovary syndrome Exclusion Criteria:

  • • Patients with BMI under 25 or over 30 Kg/m 2. – Hyper or hypothyroidism, or hyperprolactinemia. – Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs. – Intention to start a diet or a specific program of physical activity. – Organic pelvic diseases. – Tubal or male factor infertility. – Interval of earlier treatment with any of the fertility drugs of less than 6 months. – Contraindication to either: – Clomiphene citrate: liver disease, undiagnosed abnormal uterine bleeding, uterine fibroids, endometrial cancer, ovarian enlargement or hyper stimulation – HCG injection: ovarian enlargement or hyper stimulation

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohamed S Sweed, MD, Dr – Ain Shams University

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