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临床试验/CTRI/2024/09/073446
CTRI/2024/09/073446尚未招募不适用

Comparison of Clomiphene Citrate vs Human Menopausal Gonadotropin for controlled ovarian stimulation in infertile women with decreased ovarian reserve (DOR) - A randomised controlled trial

Pragya Kumari1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Proportion of mean number of dominant follicles formed in women with decreased ovarian reserve following controlled ovarian stimulation with-

研究概览

简要总结

For women with decreased ovarian reserve, controlled ovarian stimulation is done with drugs like clomiphene citrate, letrozole and injectable HMG, and very less number of studies have been done to establish the superiority of one over the other. In this study, two drugs, clomiphene citrate and injectable HMG will be compared for evaluating the efficacy of controlled ovarian stimulation over 3 cycles in women with decreased ovarian reserve. Concealed allocation by placing in sealed envelopes will be done. Each woman will be assigned one envelope and would be categorised into group A and B .Group A will receive oral clomiphene citrate 50mg orally from day 2 to day 6 of menstrual cycle for 3 cycles. If patient does not ovulate in the first cycle then further 2 cycles will be tried with 100mg/day. Group B will receive injectable HMG i/m as a step up regimen starting from 75IU/day from day 2-5 of cycle and increasing every 4-7 days till a maximum dose of upto 225 IU. Comparison of proportion of mean number of dominant follicles formed during controlled ovulation stimulation among clomiphene citrate and injectable HMG over 3 cycles will be done. Further, biochemical pregnancy as defined by positive UPT, clinical pregnancy confirmed by ultrasound findings, OHSS, multiple pregnancy and miscarriage rates will be compared over the 3 cycles.

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
21.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Infertile women of decreased ovarian reserve as described by Cohen et al with one or both of the given two criteria and with a normal husband semen analysis 1 AFC less than 7 2 AMH less than 1.1ng/ml.

排除标准

  • 1 Blocked fallopian tubes bilaterally 2 Untreated intrauterine polyps 3 Untreated submucosal fibroids indenting the uterine cavity 4 Uterine malformations, intrauterine adhesions 5 Endocrine disorders-abnormal thyroid function, hyperprolactinemia.

结局指标

主要结局

Proportion of mean number of dominant follicles formed in women with decreased ovarian reserve following controlled ovarian stimulation with-

时间窗: 3 months

1. Clomiphene citrate

时间窗: 3 months

2. Gonadotropin

时间窗: 3 months

次要结局

  • To compare the following among the 2 drugs-(1.Biochemical pregnancy (as defined by positive Urine Pregnancy Test))

研究者

发起方
Pragya Kumari
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Pragya Kumari

Lady Hardinge Medical College and associated hospitals

研究点 (1)

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