Phytoestrogen, NO Donors, N-acetyl Cysteine Add Therapy to Clomiphene
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 240
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
To evaluate the effect of oral Phytoestrogen or Isosorbid mononitrate or N-acetyl cysteine as an adjuvant to clomiphene citrate on induction of ovulation and pregnancy outcomes in patients with PCOS. In this three-arm open RCT, 240 PCOS infertile women were randomly divided to 3 groups for induction of ovulation. Group A, [PE group, n= 80] patients received CC 100mg/d plus oral Phytoestrogen120 mg/ day and patients in Group B, [ISMN group, n=80] received CC 100 mg/d plus 20 mg Isosorbid mononitrate and Group C, [NAC group, n=80] patients received CC 100 mg/d plus NAC 1200 mg/day.
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients have PCOS.
- •All patients received CC 100 mg/day for 5 days starting from day 5 with successful ovulation as documented by folliculometry and midluteal serum progesterone with no pregnancy achieved.
- •All patients have patent fallopian tubes by Hysterosalpingography.
- •Their husbands have normal semen analysis according to the modified criteria of WHO.
- •All patients have normal serum prolactin and thyroid profile.
- •Any patient having vaginitis was treated before starting induction.
排除标准
- •Other causes of infertility than anovulation.
- •Diabetes or other endocrinological disorders.
- •Age > 40 years.
- •Alcohol use.
- •Presence of ovarian cyst >2cm on the second day of the cycle.
- •Patients who have received gonadotrophins in the preceeding 6 months.
- •Patients who have done unilateral or bilateral ovarian drilling.
- •Allergy to PE, NO donors or NAC
研究组 & 干预措施
Phytoestrogen
Patients received oral PE 120 mg/ day in the form of dry coated tablets (Klimadynon, Bionorica, Germany) 2 tablets three times daily from day 1 to day 12 as adjuvant to CC in the follicular phase of the cycle.
干预措施: Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine (Drug)
Isosorbid mononitrate
Patients received in addition to CC 20 mg Isosorbid mononitrate (ISMN) tablet (EFFOX, Minapharm Co., Egypt under licence of Shwartz pharma,Germany) applied vaginally from day 1 to day 12 of the cycle.
干预措施: Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine (Drug)
N-Acetyl cysteine
Patients received supplementation to CC with NAC 1200 mg/day orally (N-acetyl cysteine, Sedico, Cairo, ARE) sachets 200 mg each, as two sachets thrice daily from day 1 to day 12 of the cycle.
干预措施: Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine (Drug)
结局指标
主要结局
clinical pregnancy rate
时间窗: 6 months
次要结局
未报告次要终点
研究者
Nawara Mohamed Hashish
Assistant professor
Kasr El Aini Hospital