Clinical study of Oligocare Forte Plus versus placebo in sub-fertile males.
- Conditions
- Oligospermia,
- Registration Number
- CTRI/2020/12/029590
- Lead Sponsor
- Meyer Organics Pvt Ltd
- Brief Summary
Male factor infertility accounts for up to half of all cases of infertility and affects one man in 20 in the general population. Evidence now suggests that reactive oxygen species (ROS)-mediated damage to sperm is a significant contributing pathology in 30–80% of cases. ROS, defined as including oxygen ions, free radicals, and peroxides, cause infertility by two principal mechanisms. First, ROS damage the sperm membrane which in turn reduces the sperm’s motility and ability to fuse with the oocyte. Secondly, ROS directly damage sperm DNA, compromising the paternal genomic contribution to the embryo. Elevated homocysteine has been linked with oxidative stress. Considering possible beneficial effects of Oligocare Forte Plus it is believed to be useful in the treatment of subfertility in males. Taking leads from nutraceutical principles, Meyer Organics Pvt. Ltd. has developed “Oligocare Forte Plusâ€, for the effective management of subfertility in males. This possesses spermatogenetic activity also helps increase secretion of androgens, reduce free radicals, nourish sperm, decrease stress, and promote overall wellbeing. The present clinical study titled “A prospective, randomized, double-blind, placebo-controlled, parallel-arm study to assess the efficacy & safety of Oligocare Forte Plus versus placebo in sub-fertile males.†is planned in 300 subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 300
- Willingness to provide written informed consent to participate in the study and willing to follow up.
- The female partner was defined as being fertile Semen analysis indicating any 2 of the following criteria- Semen volume <1.5ml Sperm count < 15 x 106/ml Motile count< 25% /106ml should read as Motile count <25% Abnormal morphology < 4% normal form.
- DNA fragmentation >20% Subjects with Oligospermia, Asthenospermia, Teratospermia Female partners of the male subjects with reported pre-existing fertility disorders can still be considered.
- General and endocrinological disease (clinical examination and routine hormonal laboratory tests) Previous or present cryptorchidism or genital obstruction.
- H/o Vasectomy, undescended testis, prostate cancer, varicocele, hydrocele.
- H/o chemotherapy or radiation for malignant conditions.
- H/o Azoospermia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate safety and efficacy of Oligocare Forte Plus by assessing- Baseline to end of study i.e. day 90 Total sperm count in sub-fertile male. Baseline to end of study i.e. day 90 Reduction in DNA Fragmentation in sub fertile male. Baseline to end of study i.e. day 90
- Secondary Outcome Measures
Name Time Method To evaluate safety and efficacy of Oligocare Forte Plus by assessing following parameters in sub fertile male- Total semen volume
Trial Locations
- Locations (12)
ARMC IVF Fertility Centre
🇮🇳Thrissur, KERALA, India
Bengal Infertility & Reproductive Therapy Hospital (BIRTH)
🇮🇳Kolkata, WEST BENGAL, India
Fertility Associates- Centre for Assisted Reproduction
🇮🇳(Suburban), MAHARASHTRA, India
Garbba Rakshambigai Fertility Centre
🇮🇳Chennai, TAMIL NADU, India
Global Medical Solutions
🇮🇳Kozhikode, KERALA, India
Infertility Specialist and Endoscopist
🇮🇳Bhopal, MADHYA PRADESH, India
Mangalya Nursing Home & Atharva Fertility Centre
🇮🇳Solapur, MAHARASHTRA, India
Phoenix Specialty clinic
🇮🇳Bangalore, KARNATAKA, India
Revive Clinic
🇮🇳Hyderabad, TELANGANA, India
Sabine Hospital & Research Centre Pvt. Ltd
🇮🇳Ernakulam, KERALA, India
Scroll for more (2 remaining)ARMC IVF Fertility Centre🇮🇳Thrissur, KERALA, IndiaDr Venugopal MPrincipal investigator9846070109venuivf@gmail.com