N-acetyl Cysteine as an Adjuvant Therapy to Laparoscopic Ovarian Drilling in Clomiphene Citrate Resistant Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- ovulation rate
研究概览
简要总结
Polycystic ovary syndrome is a major endocrinological disorder affecting 5-8% of reproductive aged women. Anovulation is a major feature of the syndrome, managed primarily by clomiphene citrate. Failure to respond to clomiphene citrate is termed clomiphene resistance and second line treatment is either laparoscopic ovarian drilling or gonadotrophin ovulation induction. Although laparoscopic drilling is effective in restoring ovulation and achieving pregnancy, some women still remain anovulatory and infertile after the procedure. N-acetyl cysteine has emerged as a novel therapeutic adjuvant to laparoscopic drilling to improve ovulation and pregnancy rate.
详细描述
Resistance to ovulation induction therapy with clomiphene citrate (CC) is a significant problem affecting as many as 25% of patients. Laparoscopic ovarian drilling is an accepted second line treatment option, achieving ovulation in 75-90% and pregnancy in 50-69% of the CC resistant patients.
Adjuvants to laparoscopic drilling have been explored by researchers some studies have shown evidence of improved outcome with the use of N-Acetyl cystiene (NAC), a long used mucolytic drug which has been used for various other indications including detoxification and cancer chemoprotection. Several studies have addressed the possibility of using NAC as adjuvant therapy to Clomiphene citrate for induction of ovulation in resistant patients with some showing encouraging results. The use of NAC as adjuvant to laparoscopic ovarian drilling was addressed in a single pilot study showing good results with improved ovulation and pregnancy rates compared to the non users.
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
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS patients according to Rotterdam criteria who failed to respond to 6 month ovulation induction therapy with clomiphene citrate,
- •normal semen analysis of partner
- •normal tubo-peritoneal anatomy as assessed by laparoscopy
排除标准
- •patients who have other causes of infertility
- •patients receiving gonadotrophin ovulation induction
研究组 & 干预措施
laparoscopic drilling group
laparoscopic drilling only will be done
干预措施: laparoscopic ovarian drilling (Procedure)
N-Acetyl cysteine
Laparoscopic ovarian drilling followed by NAC 1200mg daily in two divided doses for five days starting cycle day 2 for 6 month
干预措施: N-Acetyl cysteine (Drug)
N-Acetyl cysteine
Laparoscopic ovarian drilling followed by NAC 1200mg daily in two divided doses for five days starting cycle day 2 for 6 month
干预措施: laparoscopic ovarian drilling (Procedure)
结局指标
主要结局
ovulation rate
时间窗: 6 month
ovulation will be assessed by serial transvaginal ultrasound monitoring when feasible or day 21 serum progesterone
次要结局
- pregnancy rate(2 years)
研究者
esraa yousef badran
Esraa yousef Badran
Assiut University