A Study to Assess the Effect of Libifem® (VL-GF-01) on Fertility in Women With Diminished Ovarian… (NCT06826716) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study to Assess the Effect of Libifem® (VL-GF-01) on Fertility in Women With Diminished Ovarian Reserve
India150 participantsStarted 2025-02-10
Plain-language 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%.
Who can participate
Age range25 Years – 35 Years
SexFEMALE
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Inclusion criteria
âś“. Individuals ready to give voluntary, written informed consent to participate in the study.
âś“. Women of age between 25 to 35 years who wish to conceive.
âś“. Women with BMI between 18.5 to 34.9 kg/m2 (both values included).
âś“. Women who are unable to conceive for at least one year with an unprotected sexual life.
âś“. Women engaging in sexual act regularly and agree to continue the same at least twice a week during the study.
âś“. Women with bilateral tubal patency as confirmed by reports (within last one year from screening) of Hysterosalpingography (HSG) or Sonosalpingography (SSG).
✓. Eumenorrheic women with a regular menstrual cycle of 28 ± 5 days.
âś“. Women with Hemoglobin levels greater than or equal to 10 g/dL.
Exclusion criteria
âś•. Any chronic illness like hyper-prolactinemia.
âś•. 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).
âś•. Females clinically diagnosed with Polycystic Ovarian Syndrome (PCOS).
âś•
What they're measuring
1
To assess the effect of the Investigational product (IP) on time to pregnancy (TTP) as assessed by serum levels of Beta-human Chorionic Gonadotropin (Beta-hCG).