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 range
25 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Women engaging in sexual act regularly and agree to continue the same at least twice a week during the study.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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).