跳至主要内容
临床试验/CTRI/2024/03/063714
CTRI/2024/03/063714尚未招募Unknown

Cabergoline as an Adjunct to Ovulation Induction in Infertile Women with Endometriosis: An Open-label Randomized Study

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月16日最近更新:

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

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Garima Kachhawa

AIIMS

研究点 (1)

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