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)