Clinical study of Oligocare Forte Plus versus placebo in sub-fertile males.
- Conditions
- Health Condition 1: N461- Oligospermia
- Registration Number
- CTRI/2020/12/029590
- Lead Sponsor
- Meyer Organics Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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- <br/ ><br>Total sperm count in sub-fertile male. <br/ ><br>Reduction in DNA Fragmentation in sub fertile male.Timepoint: 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- <br/ ><br>Total semen volume <br/ ><br>Sperm motility <br/ ><br>Sperm morphology <br/ ><br>Overall pregnancy incidence amongst the study couple <br/ ><br>Timepoint: Baseline to end of study i.e. day 90