Evaluation of Uterine Biophysical Profile to assess the efficacy of Uttarbasti among Unexplained Infertility.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- To assess the efficacy of Uttarbasti on the uterine biophysical profile in unexplained infertility
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To assess the efficacy of Uttarbasti on the uterine biophysical profile in unexplained infertility
Time Frame: After each Uttarbasti cycle
Secondary Outcomes
- 1. To investigate for the confirmation of unexplained infertility(2. To evaluate the changes in uterine biophysical profile through ultrasound.)
Investigators
Dr Namrata Tambe
Bharati vidyapeeth college of Ayurved pune