Cabergoline as an Adjunct to Ovulation Induction in Infertile Women with Endometriosis: An Open-label Randomized Study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ovulation rate
研究概览
简要总结
Endometriosis is a chronic inflammatory disease associated with infertility in upto 50% patients. The standard therapy for these patients is ovulation induction, which has success rate of around 50%. Cabergoline is antiangiogenic drug used to improve ovulation in women with hyperprolactinoma and PCOS. IT also reduces the level of inflammatory markers in peritoneum. therefore, our proposed approach involves utilizing cabergoline as an adjunct to ovulation induction plus intrauterine insemination cycles for infertility in endometriosis patients. This strategy aims to reduce peritoneal inflammation and progression of endometriosis without adversely affecting ovulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 22.00 Year(s) 至 38.00 Year(s)(—)
- 性别
- Female
入选标准
- •Infertile women with clinically diagnosed endometriosis, with patent tubes, AMH level more than 1.5, AFC count more than 6, husband semen analysis within normal limits.
排除标准
- •BMI more than 35, compromised tubal function or bilateral tubal block, moderate to severe male factor infertility, grade 3,4 endometriosis, chronic inflammatory disorders, history of allergy to any study drugs, patients with decreased ovarian reserve.
结局指标
主要结局
Ovulation rate
时间窗: 1, 2, 3, 4 cycles
次要结局
- Cummulative pregnancy rate(4 months)
- endometrial thickness(1,2,3,4)
- pretreatment im]nflammatory markers with ovulation and pregnancy rate(1,4)
- incidence of dysmenorrhea and dyspareunia by visual analog scale(1,2,3,4)
研究者
Dr Garima Kachhawa
AIIMS
