Health Condition 1: N979- Female infertility, unspecified
Conditions
Interventions
Intervention1: VL-GF-01: 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
Control Intervention1: Placebo (Malto
Sponsors
Vedic Lifesciences Pvt. Ltd
Eligibility
Inclusion 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 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.10 g/dL
Exclusion criteria
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 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 22. Lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).Timepoint: 4 menstrual cycles from randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the impact of the IP as compared to baseline and placebo on: 1.Ovulation status as assessed by Antral follicle count (AFC) using Transvaginal ultrasonography (TVS) [On day 2 & day 10 of each menstrual cycle] 2.Change in serum follicle-stimulating hormone (FSH) levels [On day 2 of each menstrual cycle] 3.Change in serum Estradiol levels [On day 2 & day 10 of each menstrual cycle] 4.Ovarian reserve as assessed by serum levels of Anti-Mullerian Hormone (AMH) [On day 2 of each menstrual cycle]Timepoint: 6 menstrual cycles from screening | — |
Countries
India
Contacts
Public ContactDr Shubhangi Mote
Vedic Lifesciences Pvt Ltd
Outcome results
None listed