Effect of Herbal Supplement on Improving Sperm Virility
ConditionHealthy Human Volunteers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age25-45
SponsorGENCOR Lifestage Solutions
About this trial
The purpose of this study is to evaluate the efficacy of LN18178 on improving sperm virility.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
LN18178
Dietary supplement400 mg, One capsule to be consumed in the morning after breakfast for 12 weeks.
Placebo
Dietary supplementOne capsule to be consumed in the morning after breakfast for 12 Weeks
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: LN18178Experimental treatment 1 intervention
Group B: PlaceboOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in motility (% Motile Sperms) using manual microscopic examination.
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.
Time frame
Screening, weeks 8, 12 & 16Secondary outcomes
1
Change in semen Concentration (millions/mL) using manual microscopic examination.
Measured manually using a Makler counting chamber. Concentration is expressed in millions of sperm per milliliter. Higher concentration indicates better fertility potential.
Time frame
Screening, weeks 8, 12 & 162
Change from baseline to the end of the study period in Morphology of sperm (% normal forms) using manual microscopic examination.
Assessed through microscopic evaluation following WHO criteria. The percentage of sperm with normal morphology will be reported. Greater % indicates enhanced fertility potential.
Time frame
Screening, weeks 8, 12 & 163
Change from baseline to the end of the study period in Sperm DNA fragmentation Index (% DFI) using Sperm Chromatin Dispersion method.
Assessed using the SCD (Sperm Chromatin Dispersion) method. The DNA Fragmentation Index (DFI) represents the percentage of sperm with fragmented DNA. A decrease in DFI is associated with improved fertilization potential.
Time frame
Screening, Weeks 12 & 164
Change from baseline to the end of the study period in International Index of Erectile Function (IIEF-15)
A validated, self-administered questionnaire consisting of 15 items covering erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Each item scored from 0 to 5; total score ranges from 0 to 75. Higher scores indicate better sexual function.
Time frame
Baseline (day 1), Weeks 4, 8,12 & 16Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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