NAC in CC Resistant PCOS After LOD

Phase 2

Completed

• Conditions: Clomiphene Citrate Resistant Polycystic Ovary Syndrome
• Interventions: Drug: N-acetyl-cysteine; Drug: Clomiphene citrate

• Registration Number: NCT02775734
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-18
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-acetyl-cysteine	N-acetyl-cysteine	N-acetyl-cysteine + Clomiphene citrate + LOD
NO N-acetyl-cysteine	Clomiphene citrate	Clomiphene citrate + LOD
N-acetyl-cysteine	Clomiphene citrate	N-acetyl-cysteine + Clomiphene citrate + LOD

Primary Outcome Measures

Name	Time	Method
Biochemical pregnancy rate	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt