Overview

NAC in CC Resistant PCOS After LOD

Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ain Shams University
Treatments:
Acetylcysteine
Citric Acid
Clomiphene
Enclomiphene
N-monoacetylcystine
Zuclomiphene
Criteria
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