Female FertilityNCT06826716
A Study to Assess the Effect of Libifem® (VL-GF-01) on Fertility in Women With Diminished Ovarian Reserve
A study testing Fenugreek (Trigonella foenum graecum) in people with Female Fertility, run by Vedic Lifesciences Pvt. Ltd. at 7 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Female Fertility
- What is being tested?
- Fenugreek (Trigonella foenum graecum)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 7 sitesIndia
- Study dates
- 10 Feb 2025to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- Eumenorrheic women with a regular menstrual cycle of 28 ± 5 days.
- Women with Hemoglobin levels greater than or equal to 10 g/dL.
- Women with Anti-Mullerian hormone (AMH) greater than 0 and less than 1.5 ng/ml on day 2 of menstrual cycle.
- Females with serum Thyroid-stimulating hormone (TSH) levels between 0.4 mIU/L to 5 mIU/L [both values inclusive] with or without medication.
- Women who are not pregnant during the time of screening as assessed by UPT.
- Women who have never undergone IVF procedure.
- Women with their male partners having an acceptable serum analysis report as per PI.
- Women willing to complete all study-related assessments and to complete all clinical study visits as per the protocol.
Who cannot join
- 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).
- Females with a prior history (within the last 6 months from screening) of ≥3 cycles of ovulation induction.
- History of ovarian hyper-response.
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- History of any endocrine abnormality (eg: Adrenal gland disorders, pituitary disorders, endocrine diseases, dyslipidemia, etc.).
- Females previously diagnosed with hyperparathyroidism and/or hyperthyroidism.
- Females with a history of any psychiatric disorder.
- Currently undergoing or have previously undergone Hormone Therapy (HT) for treatment of fertility in the previous 6 months.
- Currently consuming Ayurvedic/dietary supplements, and/or currently consuming steroids or if consumed in the last 3 months before screening.
- Currently consuming cytotoxics and immunosuppressants.
- History of uncontrolled hypertension and/or systolic blood pressure greater than equal to 140 mmHg and/or diastolic blood pressure greater than equal to 90 mmHg.
- Fasting blood glucose (FBG) greater than or equal to 126 mg/dL.
- Participation in other clinical studies in the past 3 months.
- History of alcohol or drug abuse in the 12 months prior to screening.
- History of cancer.
- Hematological disorders.
- History or presence of any Sexually Transmitted Disease (STD).
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential individual at risk because of participation in the study, or influences the results or the potential individual's ability to participate in the study.
- History or presence of HIV, cardiovascular, gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e. Crohn's disease, short bowel, acute or chronic pancreatitis or pancreatic insufficiency).
- Lactating women
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
India7 sites
Sachi Hospital
Ahmedabad, Gujarat, 380008
Dr. Kinjal Thakkar, MBBS, MBDGO, 7285824742, kinjalthakkar44@gmail.com
Shardaben General Hospital
Ahmedabad, Gujarat, 380018.
Dr. Samipa J. Shah, MBBS, MD, 9898263933, dr.samipashah04@gmail.com
Panchsheel Hospital Pvt. Ltd.
Delhi, 110053
Dr. Poonam Goyal, MBBS, MD, 9811081811, goyalpoonam29@gmail.com
Jnu ,Jaipur
Jaipur, Rajashthan, 302017
Dr. Neha Vasishth, MBBS, DNB, 7597060296, vashisthdrneha@gmail.com
Imperial Multispeciality Hospital
Pune, Maharashtra, 411062.
Ashwin Medical Foundations Moraya Multispeciality Hospita
Pune, Maharshtra, 411033
Dr. Archana Chandak, MBBS,DGO, 9890778855, amchandak2000@yahoo.com
Pragya Mother & Child care Hospital
Varanasi, Uttar Pradesh, 221005
Dr. Pragya Pandey, MBBS, MS, 9696519115, pragyamadhukar@gmail.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effect of Libifem® (VL-GF-01) on Fertility in Women With Diminished Ovarian Reserve
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%.
- Conditions
- Female Fertility
- Being tested
- Fenugreek (Trigonella foenum graecum), Placebo (Maltodextrin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenugreek (Trigonella foenum graecum)Dietary supplement
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
Placebo (Maltodextrin)Dietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| IP(Trigonella foenum graecum)) | Experimental | 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 Receives: Dietary Supplement: Fenugreek (Trigonella foenum graecum) |
| Placebo (Maltodextrin) | Placebo comparator | 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 Receives: Dietary Supplement: Placebo (Maltodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Date of screening upto 6 month
Secondary outcomes (4)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: From Date of screening upto 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start10 Feb 2025 (estimated)
- Primary completion5 Dec 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female FertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment A randomized, double-blind, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826716
- Sponsor's protocol ID
- GR/240801/IP/FF
- Status last verified
- Feb 2025
- First submitted
- 17 Dec 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effect of Libifem® (VL-GF-01) on Fertility in Women With Diminished Ovarian Reserve
- ClinicalTrials.gov ID
- NCT06826716
- Acronym / sponsor ID
- GR/240801/IP/FF
- Conditions
- Female Fertility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2025 (estimated)
- Primary completion
- 5 Dec 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment A randomized, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| IP(Trigonella foenum graecum)) | Experimental | 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 |
| Placebo (Maltodextrin) | Placebo comparator | Dietary Supplement: Placebo (Maltodextrin)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 |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (22 listed)
- 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).
- Females with a prior history (within the last 6 months from screening) of ≥3 cycles of ovulation induction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | IP(Trigonella foenum graecum)) |
| Placebo (Maltodextrin)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) |
Primary outcome
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).
Time frame: From Date of screening upto 6 month
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
4 secondary outcomes
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)
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)
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)
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]
Time frame: From Date of screening upto 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Factors Influencing Fertility or Pregnancy Health
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fenugreek (Trigonella foenum graecum) in people with Female Fertility, run by Vedic Lifesciences Pvt. Ltd. at 7 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Sanjay Vaze, MBBS (8655670964, sanjay.v@vediclifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: From Date of screening upto 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.