An interventional study of Fenugreek (Trigonella foenum graecum) and Placebo (Maltodextrin) in Female Fertility, sponsored by Vedic Lifesciences Pvt. Ltd.. Not yet recruiting at 7 sites in India. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Vedic Lifesciences Pvt. Ltd. · Not applicable, Interventional, and Treatment
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%.
Vedic Lifesciences Pvt. Ltd. is the lead sponsor of 72 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: 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)
Drug page: Fenugreek seed meal
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
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
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).
The mid-cycle surge in LH lasts 36-48 hours and triggers ovulation, which is the release of the egg from the follicle. The peak progesterone levels occur halfway through the last 14 days of the cycle, known as the luteal phase. Progesterone prepares the endometrium for potential implantation if the egg is fertilized and forms an embryo. If an embryo develops, it produces human chorionic gonadotropin (hCG), which activates the Luteinizing Hormone (LH) receptors and helps maintain the corpus luteum's function, allowing it to continue producing progesterone and supporting the pregnancy. When a participant misses her menstrual cycle after the expected cycle date, clinical pregnancy will be confirmed by the quantitative Beta-hCG test on the subsequent day 10 visi
Time frame: From Date of screening upto 6 month
To assess the impact of the IP as compared to baseline and placebo on Ovulation status as assessed by Antral follicle count (AFC) using Transvaginal ultrasonography (TVS) (On day 2 & day 10 of each menstrual cycle)
The antral follicle count (AFC) evaluates the number of visible follicles in a woman's ovaries at the beginning of her menstrual cycle.The greater the number of visible follicles in the ovary, the higher the likely ovarian reserve. Women experiencing infertility are more likely to have lower antral follicle counts compared to those who are not infertile.TVS offers a precise and consistent measurement of the total number of antral follicles throughout the menstrual cycle.Thus, AFC will be assessed using TVS on days 2 and 10 of each menstrual cycle throughout the Study
Time frame: From Date of screening upto 6 month
To assess the impact of the IP as compared to baseline and placebo on Reduction in serum Follicle-Stimulating Hormone levels(On day 2 of each menstrual Cycle)
FSH levels are highest just before ovulation in the follicular phase and help in the development of the follicles. The levels decrease after the onset of menstruation because of the negative feedback mechanism of inhibin B and estrogen.
Time frame: From Date of screening upto 6 month
To assess the impact of the IP as compared to baseline and placebo on Reduction in serum Estradiol levels(On day 2 & day 10 of each menstrual cycle)
Like FSH, estradiol levels fluctuate throughout the menstrual cycle, reaching peaks in both the late follicular and mid-luteal phases. A reduction in the estradiol levels in the menstrual phase can lead to a replenished ovarian reserve. Thus, in the present study, the serum estradiol levels will be analyzed on day 2 and day 10 of each menstrual cycle throughout the study
Time frame: From Date of screening upto 6 month
To assess the impact of the IP as compared to baseline and placebo on Change in the ovarian reserve as assessed by serum Anti-Mullerian hormone levels [On day 2 of each menstrual cycle]
Anti-Mullerian Hormone (AMH). AMH is a sensitive biomarker of ovarian reserve, as its levels decline before FSH increases. This test demonstrates a strong correlation between the primordial follicle pool and ovarian response to stimulation .AMH has several advantages over traditional ovarian reserve markers: it is the first to change with age, shows minimal variability within a single cycle and between consecutive cycles, and can be measured at any point during the cycle.37 Therefore, in the present study, AMH levels will be analyzed on day 2 of each menstrual cycle throughout the study
Time frame: From Date of screening upto 6 month
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2025; primary completion for Dec 2025, 9 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Fenugreek seed meal
Vedic Lifesciences Pvt. Ltd. →