NCT06826716

A Study to Assess the Effect of Libifem® (VL-GF-01) on Fertility in Women With Diminished Ovarian Reserve

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: Female
• Age: 25 Years – 35 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Female Fertility

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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
DIETARY_SUPPLEMENT	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

Timeline

• Start date: 2025-02-10
• Primary completion: 2025-12-05
• Completion: 2025-12-10
• First posted: 2025-02-14
• Last updated: 2025-02-14

Locations

7 sites across 1 country: India