About this trial
The purpose of this study is to evaluate the efficacy of LN18178 on improving sperm virility.
Eligibility criteria
Qualifiers
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
Treatments tested in this trial
- LN18178
- Placebo