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A Study to Assess the Effect of Libifem® (VL-GF-01) on Fertility in Women With Diminished Ovarian Reserve
Sponsor: Vedic Lifesciences Pvt. Ltd.
Summary
The present study is a randomized, double-blind, placebo-controlled, parallel clinical study. Approximately 156 participants will be screened, and considering a screening failure rate of 20%, not more than 124 participants will be randomized in a ratio of 1:1 to receive either Libifem® or placebo and will be assigned a unique randomization code. Each group will have not less than 50 completed participants after accounting for a dropout/withdrawal rate of 20%.
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effect of Libifem® (VL-GF-01) on Fertility in Women With Diminished Ovarian Reserve
Key Details
Gender
FEMALE
Age Range
25 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-02-10
Completion Date
2025-12-10
Last Updated
2025-02-14
Healthy Volunteers
No
Conditions
Interventions
Fenugreek (Trigonella foenum graecum)
Dose: 600 mg/day Regimen: One capsule (300 mg) to be taken twice a day 30 minutes post breakfast and dinner Route of administration: Oral
Placebo (Maltodextrin)
Dose: 600 mg/day Regimen: One capsule (300 mg) to be taken twice a day 30 minutes post breakfast and dinner Route of administration: Oral
Locations (7)
Sachi Hospital
Ahmedabad, Gujarat, India
Shardaben General Hospital
Ahmedabad, Gujarat, India
Imperial Multispeciality Hospital
Pune, Maharashtra, India
Ashwin Medical Foundations Moraya Multispeciality Hospita
Pune, Maharshtra, India
Jnu ,Jaipur
Jaipur, Rajashthan, India
Pragya Mother & Child care Hospital
Varanasi, Uttar Pradesh, India
Panchsheel Hospital Pvt. Ltd.
Delhi, India