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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 14
- 主要终点
- 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).
研究概览
简要总结
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%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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).
时间窗: 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
次要结局
- 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 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)
- 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)