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临床试验/CTRI/2024/07/071335
CTRI/2024/07/071335尚未招募4 期

Comparison of efficacy of clomiphene citrate and tamoxifen for controlled ovarian stimulation in women with unexplained infertility: Randomised Control Trial.

Deepika Singh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Comparison of mean number of dominant follicles formed during controlled ovulation stimulation among clomiphene citrate and tamoxifen over 3 cycles.

研究概览

简要总结

For women with unexplained infertility, COS is done with oral ovulogens , clomiphene citrate and tamoxifen, superiority of one over the other is not yet established. In this study, two oral ovulogens, clomiphene citrate and tamoxifen will be compared for evaluating the efficacy and safety for controlled ovarian stimulation over 3 cycles in women with unexplained infertility. Concealed allocation by placing in sealed envelopes will be done. Each women will be assigned one envelope and would be categorized into group A and B .Group A will receive 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 dose will be increased to 100mg in subsequent cycle .Group B will receive tamoxifen 20 mg from day 2 to day 6 for three cycles. If patient does not ovulate in the first cycle then dose will be increased to 40 mg in subsequent cycle. Comparison of mean number of dominant follicles formed during controlled ovulation stimulation among clomiphene citrate and tamoxifen over 3 cycles will be done. Further ,Mean Endometrial thickness, Mean resistivity index and pulsatility index of ovarian and uterine artery, Proportion of women with biochemical pregnancy (urine pregnancy test positive), Proportion of women with clinical pregnancy 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 38.00 Year(s)(—)
性别
Female

入选标准

  • Women with unexplained infertility (whether primary or secondary in which couple fails to achieve pregnancy after 1 year of unprotected and regular intercourse) with following criteria: 1 Normal husband semen analysis 2 Patent fallopian tube on HSG/ chromopertubation 3 Normal uterine cavity on USG 4 Normal ovulatory function.

排除标准

  • Patients with any of the following: 1 Hormonal imbalance (hypothyroidism, insulin resistance and hyperprolactinemia) 2 History of ovarian or uterine tumour 3 AFC less than 5, AMH less than 1ng/ml 4 BMI greater than 35kg/m2 or higher 5 Resistance to clomiphene citrate or tamoxifen 6 Predicted decreased endometrial receptivity ,intrauterine abnormalities, adhesions and chronic endometritis, uterine polyp or submucosal fibroid).

结局指标

主要结局

Comparison of mean number of dominant follicles formed during controlled ovulation stimulation among clomiphene citrate and tamoxifen over 3 cycles.

时间窗: 3 months

次要结局

  • To compare the following parameters among the two drugs.(1.Mean Endometrial thickness)

研究者

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

Dr Deepika Singh

Lady Hardinge medical college and associated hospitals

研究点 (1)

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