NAC in CC Resistant PCOS After LOD

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Treatments: Drug: N-acetyl-cysteine; Drug: Clomiphene citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02775734

AS1275

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups

N-acetyl-cysteine

Active Comparator group

Description:

N-acetyl-cysteine + Clomiphene citrate + LOD

Treatment:

Drug: N-acetyl-cysteine

Drug: Clomiphene citrate

NO N-acetyl-cysteine

Active Comparator group

Description:

Clomiphene citrate + LOD

Treatment:

Drug: Clomiphene citrate