Evaluation of Uterine Biophysical Profile to assess the efficacy of Uttarbasti among Unexplained Infertility.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Uttarbasti on the uterine biophysical profile in unexplained infertility
研究概览
简要总结
This is a prospective, interventional, single-arm pilot clinical trial designed to evaluate the effect of Uttarbasti using Phala Ghrita on the uterine biophysical profile in women diagnosed with unexplained infertility. A total of 10 participants aged 20–40 years will be enrolled.
Each participant will undergo three cycles of Uttarbasti, administered under aseptic precautions. Ultrasound-based Uterine Biophysical Profile (including endometrial thickness, layering, vascularity, myometrial features, and Doppler indices) will be assessed at baseline and after each treatment cycle (between Day 12–16 of the menstrual cycle). Safety will be ensured through monitoring of vitals, adverse events, and procedural precautions.
The study aims to determine whether Uttarbasti improves parameters essential for implantation and fertility, thereby providing preliminary evidence on the therapeutic role of Uttarbasti in unexplained infertility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged between 20-40 years.
- •Women unable to conceived since last 1 year in spite of having regular sexual contact.
- •Individuals diagnosed with unexplained infertility.
- •Consent to participate in the study.
排除标准
- •Pregnant women
- •Women with a miscarriage in last one year.
- •Women with severe hormonal imbalances or undergoing hormonal therapy in last one year.
- •Individuals with any underlying chronic conditions hypertension.
结局指标
主要结局
To assess the efficacy of Uttarbasti on the uterine biophysical profile in unexplained infertility
时间窗: After each Uttarbasti cycle
次要结局
- 1. To investigate for the confirmation of unexplained infertility(2. To evaluate the changes in uterine biophysical profile through ultrasound.)
研究者
Dr Namrata Tambe
Bharati vidyapeeth college of Ayurved pune