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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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | The antral follicle count (AFC) evaluates the number of visible follicles in a woman's ovaries at the beginning of her menstrual cycle.The greater the number of visible follicles in the ovary, the higher the likely ovarian reserve. Women experiencing infertility are more likely to have lower antral follicle counts compared to those who are not infertile.TVS offers a precise and consistent measurement of the total number of antral follicles throughout the menstrual cycle.Thus, AFC will be assessed using TVS on days 2 and 10 of each menstrual cycle throughout the Study |
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Inclusion Criteria:
Exclusion Criteria:
Female fertility
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sanjay Vaze, MBBS | Contact | 8655670964 | sanjay.v@vediclifesciences.com | |
| Dr Shubhangi Mote, BAMS | Contact | 8655448527 | shubhangi.m@vediclifesciences.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sachi Hospital | Ahmedabad | Gujarat | 380008 | India |
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Parallel Assignment A randomized, double-blind, placebo-controlled study
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| 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 |
|
| 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) | FSH levels are highest just before ovulation in the follicular phase and help in the development of the follicles. The levels decrease after the onset of menstruation because of the negative feedback mechanism of inhibin B and estrogen. | 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) | Like FSH, estradiol levels fluctuate throughout the menstrual cycle, reaching peaks in both the late follicular and mid-luteal phases. A reduction in the estradiol levels in the menstrual phase can lead to a replenished ovarian reserve. Thus, in the present study, the serum estradiol levels will be analyzed on day 2 and day 10 of each menstrual cycle throughout the study | 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] | Anti-Mullerian Hormone (AMH). AMH is a sensitive biomarker of ovarian reserve, as its levels decline before FSH increases. This test demonstrates a strong correlation between the primordial follicle pool and ovarian response to stimulation .AMH has several advantages over traditional ovarian reserve markers: it is the first to change with age, shows minimal variability within a single cycle and between consecutive cycles, and can be measured at any point during the cycle.37 Therefore, in the present study, AMH levels will be analyzed on day 2 of each menstrual cycle throughout the study | From Date of screening upto 6 month |
| Shardaben General Hospital | Ahmedabad | Gujarat | 380018. | India |
|
| Imperial Multispeciality Hospital | Pune | Maharashtra | 411062. | India |
| Ashwin Medical Foundations Moraya Multispeciality Hospita | Pune | Maharshtra | 411033 | India |
|
| Jnu ,Jaipur | Jaipur | Rajashthan | 302017 | India |
|
| Pragya Mother & Child care Hospital | Varanasi | Uttar Pradesh | 221005 | India |
|
| Panchsheel Hospital Pvt. Ltd. | Delhi | 110053 | India |
|
| ID | Term |
|---|---|
| C056164 | fenugreek seed meal |
| C008315 | maltodextrin |
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