A Study to Assess the Effect of Libifem® (VL-GF-01) on Fertility in Women With Diminished Ovarian Reserve

NCT06826716 | Not Yet Recruiting

• 1 other identifier: GR/240801/IP/FF
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

Brief 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%.

Conditions

Female Fertility

Outcome Measures

Primary Outcomes (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).

  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

  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)

  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)

  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)

  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]

  From Date of screening upto 6 month

Study Arms (2)

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

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

Dietary Supplement: Placebo (Maltodextrin)

Interventions

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

IP(Trigonella foenum graecum))

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

Placebo (Maltodextrin)

Eligibility Criteria

• Age: 25 Years - 35 Years
• Gender Eligibility Details: Female fertility
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (7)

Sachi Hospital

Ahmedabad, Gujarat, 380008, India

Location

Shardaben General Hospital

Ahmedabad, Gujarat, 380018., India

Location

Imperial Multispeciality Hospital

Pune, Maharashtra, 411062., India

Location

Ashwin Medical Foundations Moraya Multispeciality Hospita

Pune, Maharshtra, 411033, India

Location

Jnu ,Jaipur

Jaipur, Rajashthan, 302017, India

Location

Pragya Mother & Child care Hospital

Varanasi, Uttar Pradesh, 221005, India

Location

Panchsheel Hospital Pvt. Ltd.

Delhi, 110053, India

Location

MeSH Terms

Interventions

fenugreek seed meal; maltodextrin

Central Study Contacts

Dr. Sanjay Vaze, MBBS

CONTACT

8655670964; sanjay.v@vediclifesciences.com

Dr Shubhangi Mote, BAMS

CONTACT

8655448527; shubhangi.m@vediclifesciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment A randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: February 14, 2025
• Study Start: February 10, 2025
• Primary Completion: December 5, 2025
• Study Completion: December 10, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (7)