Not Yet RecruitingNot Applicable

Effect of Herbal Supplement on Improving Sperm Virility

40 participantsStarted 2025-08-08

Plain-language summary

The purpose of this study is to evaluate the efficacy of LN18178 on improving sperm virility.

Age range25 Years – 45 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Males aged between 25-45 years with a Body Mass Index (BMI) of 20-29 kg/m2.
✓. 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.

✕. 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.

Change in motility (% Motile Sperms) using manual microscopic examination.

Timeframe: Screening, weeks 8, 12 & 16

NCT IDNCT07109622

SponsorGENCOR Lifestage Solutions

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-10

Mr Machiraju Garga

Who can participate

Age range25 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Males aged between 25-45 years with a Body Mass Index (BMI) of 20-29 kg/m2.
✓. 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.

✕. 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.