NCT07109622尚未招募不适用
A Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Efficacy of LN18178 on Improving Sperm Virility (Sperm Motility, Sperm Concentration, and Sperm Morphology)
GENCOR Lifestage Solutions0 个研究点目标入组 40 人开始时间: 2025年8月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Change in motility (% Motile Sperms) using manual microscopic examination.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of LN18178 on improving sperm virility.
详细描述
A total of 40 Males aged between 25-45 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either LN18178 - 400 mg or placebo arms at 1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast for 12 weeks. A part from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the LN18178 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged between 25-45 years with a Body Mass Index (BMI) of 20-29 kg/m
- •Subjects with a history of infertility of at least 12 months despite regular unprotected intercourse.
- •Subjects with semen analysis showing abnormal sperm concentration (< 16 million/ml), progressive motility (< 30%), and total motility (< 42%), normal morphology (< 4%). (WHO guidelines- 6th edition, 2021)
- •Subjects with total testosterone ≥300 ng/dL.
- •Subjects who are willing to abstain from sexual activity that results in ejaculation for 3 to 5 days before semen analysis.
- •Subjects who are in a stable sexual relationship and sexually active during the study.
- •Subjects willing to use contraceptives during study period.
- •Subjects agree to maintain current diet and activity level.
- •No urogenital infection or anatomical abnormality of this system, including varicocele; no prior history of surgery in the pelvic area; no uncontrolled systemic illness, such as liver and gallbladder cancers, renal failure, thyroid disorders, and cerebral haemorrhage; no prior history of trauma to the testes; no unilateral testicular atrophy; no previous history of chemotherapy or treatment with anticoagulants, corticosteroids, testosterone and anti-androgen medications during the 8 weeks before the study.
- •Subject considered generally healthy as per health history and routine clinical investigations during screening.
- •Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.
排除标准
- •Employees working on night shifts.
- •Subjects with identifiable cause for Oligoasthenoteratozoospermia (OAT) (includes Cryptorchidism, Orchitis and Radiation or chemotherapy etc.).
- •Subjects with Systolic >140 and Diastolic >90 mmHg blood pressure and Fasting blood glucose (FBG) >125 mg/dl.
- •Smokers and alcoholics.
- •Subjects underwent treatment for COVID 19 within the last 3 months or tested positive during the study will be excluded.
- •Subject with any physical disability that may limit sexual function.
- •Subjects with history of taking medications for oligospermia or any other sexual problems, including PDE-5 inhibitors, and dysfunctions related to genito-urinary system, muscular dystrophy and coagulation.
- •Subjects with clinical history of genital surgery, endocrine disorders e.g. hypopituitarism, pituitary tumors, hypo- and hyperthyroidism, hypogonadism, inherited (genetic and chromosomal) disorders, etc.
- •Subjects diagnosed with sleep apnea or related disorders.
- •Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
- •Subjects who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products.
- •Subjects having history of Benign Prostate Hyperplasia (BPH), stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia within the past 6 months.
- •Subjects under medications including vitamins, antidepressants, anticholinergics, inhaled beta agonists, anti- hyperlipidemic, psychotropics etc.
- •Subjects using any centrally acting anorectic agents, drugs that inhibit the absorption of nutrients and endocannabinoid neuromodulators during the two weeks prior to enrolment into the study.
- •Subjects who underwent major surgical procedures in last 6 months, which may affect their quality of life.
- •Subject with HIV positive or any other STDs.
- •History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •Subject has participated in a clinical study within the last 90 days prior to recruitment or concurrently participating in another study.
结局指标
主要结局
Change in motility (% Motile Sperms) using manual microscopic examination.
时间窗: Screening, weeks 8, 12 & 16
Assessed through manual microscopic examination according to WHO guidelines. The percentage of motile sperm (progressive + non-progressive) will be calculated. A higher percentage reflects improved reproductive function.
次要结局
- Change in semen Concentration (millions/mL) using manual microscopic examination.(Screening, weeks 8, 12 & 16)
- Change from baseline to the end of the study period in Morphology of sperm (% normal forms) using manual microscopic examination.(Screening, weeks 8, 12 & 16)
- Change from baseline to the end of the study period in Sperm DNA fragmentation Index (% DFI) using Sperm Chromatin Dispersion method.(Screening, Weeks 12 & 16)
- Change from baseline to the end of the study period in International Index of Erectile Function (IIEF-15)(Baseline (day 1), Weeks 4, 8,12 & 16)
- Change from baseline to the end of the study period in Serum hormonal biomarkers: Luteinizing Hormone (mIU/mL) using Enzyme-Linked Immunosorbent Assay method(Baseline (day 1), Weeks 12 &16)
- Change from baseline to the end of the study period in Quality of life short form (SF-36)(Baseline (day 1), Weeks 4, 8,12 & 16)
- Change from baseline to the end of the study period in Serum hormonal biomarkers: Total Testosterone (ng/mL) using Enzyme-Linked Immunosorbent Assay method(Baseline (day 1), Weeks 12 &16)
- Change from baseline to the end of the study period in Serum hormonal biomarkers: Free Testosterone (pg/mL) using Enzyme-Linked Immunosorbent Assay method(Baseline (day 1), Weeks 12 &16)
- Change from baseline to the end of the study period in Serum hormonal biomarkers: Follicle-Stimulating Hormone (mIU/mL) using Enzyme-Linked Immunosorbent Assay method(Baseline (day 1), Weeks 12 &16)
- Change from baseline to the end of the study period in Semen oxidative stress markers GSH: Glutathione (µM) using Enzyme-Linked Immunosorbent Assay method(Baseline (day 1), Weeks 12 &16)
- Change from baseline to the end of the study period in Serum hormonal biomarkers: Inhibin B (pg/ml) using Enzyme-Linked Immunosorbent Assay method(Baseline (day 1), Weeks 12 &16)
- Change from baseline to the end of the study period in Semen oxidative stress markers MDA: Malondialdehyde (ng/mL) using Enzyme-Linked Immunosorbent Assay method(Baseline (day 1), Weeks 12 &16)
- Change from baseline to the end of the study period in Semen inflammation markers IL-6: Interleukin 6 (pg/mL) using Enzyme-Linked Immunosorbent Assay method(Baseline (day 1), Weeks 12 &16)
- Change from baseline to the end of the study period in Semen oxidative stress markers TAC: Total Antioxidant Capacity (mM) using Enzyme-Linked Immunosorbent Assay method(Baseline (day 1), Weeks 12 &16)
- Change from baseline to the end of the study period in Semen inflammation markers TNF-alpha: Tumor Necrosis Factor-Alpha (pg/mL) using Enzyme-Linked Immunosorbent Assay method(Baseline (day 1), Weeks 12 &16)
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