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

Официальное название

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

Обзор

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%.

Вмешательства

• Пищевая добавка 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
• Пищевая добавка 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

Первичные конечные точки

• 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). [Срок оценки: From Date of screening upto 6 month]

Вторичные конечные точки (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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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] [Срок оценки: From Date of screening upto 6 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Индия · 7 центров

• Sachi Hospital — Ahmedabad
• Shardaben General Hospital — Ahmedabad
• Imperial Multispeciality Hospital — Pune
• Ashwin Medical Foundations Moraya Multispeciality Hospita — Pune
• Jnu ,Jaipur — Jaipur
• Pragya Mother & Child care Hospital — Varanasi
• Panchsheel Hospital Pvt. Ltd. — Delhi

Идентификаторы

NCT: NCT06826716 · GR/240801/IP/FF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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