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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-35
SponsorVedic Lifesciences Pvt. Ltd.

About this trial

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%.

Eligibility criteria

Qualifiers

Individuals ready to give voluntary, written informed consent to participate in the study.

Women of age between 25 to 35 years who wish to conceive.

Women with BMI between 18.5 to 34.9 kg/m2 (both values included).

Women who are unable to conceive for at least one year with an unprotected sexual life.

Disqualifiers

Any chronic illness like hyper-prolactinemia.

Females diagnosed with stage 3 and stage 4 Endometriosis.

Females with a history of recurrent pregnancy loss (defined as ≥ 2 failed clinical pregnancies before 22 weeks of gestational age).

Females clinically diagnosed with Polycystic Ovarian Syndrome (PCOS).

Trial design

Treatments tested in this trial

  • Fenugreek (Trigonella foenum graecum)
  • Placebo (Maltodextrin)

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators