N-acetyl-cysteine in Clomiphene Citrate Resistant Polycystic Ovary Syndrome After Laparoscopic Ovarian Drilling: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Biochemical pregnancy rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) between 25 and 30 Kg/m
- •CC-resistant Polycystic ovary syndrome
排除标准
- •• Patients with BMI under 25 or over 30 Kg/m
- •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
研究组 & 干预措施
N-acetyl-cysteine
N-acetyl-cysteine + Clomiphene citrate + LOD
干预措施: N-acetyl-cysteine (Drug)
N-acetyl-cysteine
N-acetyl-cysteine + Clomiphene citrate + LOD
干预措施: Clomiphene citrate (Drug)
NO N-acetyl-cysteine
Clomiphene citrate + LOD
干预措施: Clomiphene citrate (Drug)
结局指标
主要结局
Biochemical pregnancy rate
时间窗: 6 months
次要结局
- 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)
研究者
Mohamed S Sweed, MD
Dr
Ain Shams University