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临床试验/CTRI/2020/06/025688
CTRI/2020/06/025688已完成1 期

Combination of Letrozole and Clomiphene Citrate VersusLetrozole alone for ovulation induction in women with polycystic ovary syndrome-a Randomized Controlled Trial

Dr Anupama Bahadur1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2020年10月6日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
84
试验地点
1
主要终点
Total number of women attaining clinical pregnancy in either group (confirmed by USG)

研究概览

简要总结

In this trial we are giving Ovulation induction with Letrozole or letrozole+ clomiphene citrate  for anovulatory PCOS females with infertility and comparing the pregnancy rate in both groups.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 38.00 Year(s)(—)
性别
Female

入选标准

  • 1-Women 20–35 years of age with PCOS(according to Rotterdam criteria).
  • 2-Primary / Secondary Infertile women with PCOS 3-BMI <30 kg/m2 4-Willing to participate in study and follow up.

排除标准

  • 1-Pregnancy 2-Patient already on other drugs for treatment of PCOS like OCPs 3-Other known cause of infertility (Endometriosis, Unexplained Infertility, Moderate to severe male factor infertility) 4-Deranged kidney or liver function tests 5-Uncontrolled Thyroid disorders 6-Untreated hyperprolactinemia 7-Women with any other endocrinological disorders 8-Medical conditions not well controlled or not recommended during pregnancy (i.e., uncontrolled type 1 or 2 diabetes mellitus, hypertension, hypothyroidism) 9-Allergy or contraindications to letrozole or CC 10-Clinical suspicion of other etiologies that mimic PCOS warranting additional evaluation.

结局指标

主要结局

Total number of women attaining clinical pregnancy in either group (confirmed by USG)

时间窗: 18 months

次要结局

  • 1.Ovulation rate(2.Number of OHSS(Ovarian Hyper-Stimulation Syndrome) cases)

研究者

发起方
Dr Anupama Bahadur
申办方类型
Other [Dr Anupama Bahadur]

研究点 (1)

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