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

Launched by VEDIC LIFESCIENCES PVT. LTD. · Feb 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Libifem® on fertility in women who have difficulty conceiving due to diminished ovarian reserve. The trial aims to include about 124 women aged between 25 and 35 years who have been trying to get pregnant for at least a year without success. To be eligible, participants must have regular menstrual cycles, a certain body weight, and specific hormone levels. They should also be in a stable relationship and willing to engage in sexual activity regularly during the study.

Participants in the trial will be randomly assigned to receive either Libifem® or a placebo (a non-active treatment) for the duration of the study. This means that neither the participants nor the researchers will know who is receiving the actual medication, helping to ensure unbiased results. Throughout the study, participants will attend regular check-ups to monitor their health and the effects of the treatment. It’s important to note that women with certain medical conditions, a history of fertility treatments, or those currently taking specific medications may not be eligible to join. This trial is not yet recruiting, but if you think you might qualify, it could be a valuable opportunity to explore potential new options for improving fertility.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Individuals ready to give voluntary, written informed consent to participate in the study.
• • 2. Women of age between 25 to 35 years who wish to conceive.
• • 3. Women with BMI between 18.5 to 34.9 kg/m2 (both values included).
• • 4. Women who are unable to conceive for at least one year with an unprotected sexual life.
• • 5. Women engaging in sexual act regularly and agree to continue the same at least twice a week during the study.
• • 6. Women with bilateral tubal patency as confirmed by reports (within last one year from screening) of Hysterosalpingography (HSG) or Sonosalpingography (SSG).
• • 7. Eumenorrheic women with a regular menstrual cycle of 28 ± 5 days.
• • 8. Women with Hemoglobin levels greater than or equal to 10 g/dL.
• • 9. Women with Anti-Mullerian hormone (AMH) greater than 0 and less than 1.5 ng/ml on day 2 of menstrual cycle.
• • 10. Females with serum Thyroid-stimulating hormone (TSH) levels between 0.4 mIU/L to 5 mIU/L \[both values inclusive\] with or without medication.
• • 11. Women who are not pregnant during the time of screening as assessed by UPT.
• • 12. Women who have never undergone IVF procedure.
• • 13. Women with their male partners having an acceptable serum analysis report as per PI.
• • 14. Women willing to complete all study-related assessments and to complete all clinical study visits as per the protocol.
• Exclusion Criteria:
• • 1. Any chronic illness like hyper-prolactinemia.
• • 2. Females diagnosed with stage 3 and stage 4 Endometriosis.
• • 3. Females with a history of recurrent pregnancy loss (defined as ≥ 2 failed clinical pregnancies before 22 weeks of gestational age).
• • 4. Females clinically diagnosed with Polycystic Ovarian Syndrome (PCOS).
• • 5. Females with a prior history (within the last 6 months from screening) of ≥3 cycles of ovulation induction.
• • 6. History of ovarian hyper-response.
• • 7. History of any endocrine abnormality (eg: Adrenal gland disorders, pituitary disorders, endocrine diseases, dyslipidemia, etc.).
• • 8. Females previously diagnosed with hyperparathyroidism and/or hyperthyroidism.
• • 9. Females with a history of any psychiatric disorder.
• • 10. Currently undergoing or have previously undergone Hormone Therapy (HT) for treatment of fertility in the previous 6 months.
• • 11. Currently consuming Ayurvedic/dietary supplements, and/or currently consuming steroids or if consumed in the last 3 months before screening.
• • 12. Currently consuming cytotoxics and immunosuppressants.
• • 13. 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.
• • 14. Fasting blood glucose (FBG) greater than or equal to 126 mg/dL.
• • 15. Participation in other clinical studies in the past 3 months.
• • 16. History of alcohol or drug abuse in the 12 months prior to screening.
• • 17. History of cancer.
• • 18. Hematological disorders.
• • 19. History or presence of any Sexually Transmitted Disease (STD).
• • 20. 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.
• • 21. 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).
• • 22. Lactating women