Effect of Natural Antioxidant Supplement on Sperm DNA Fragmentation
- Conditions
- Observe Effect of Antioxidant on Sperm DNA Fragmention
- Interventions
- Dietary Supplement: Natural Antioxidant supplement
- Registration Number
- NCT03646825
- Lead Sponsor
- Colorado Center for Reproductive Medicine
- Brief Summary
Observational study to see the effect of use of natural Antioxidant supplement on sperm DNA fragmentation. Subjects will take the natural antioxidant for 3 months prior to repeat testing.
- Detailed Description
Male patients will be recruited based on having a high DNA fragmentation (chromatin \>16) no other severe male factor infertility (\>5million/ml, count, \> 10%motility and \>1% morphology) and sufficient ejaculate sperm for ICSI (no surgically removed sperm or history of vasectomy reversal). Patients will be provided the natural antioxidant supplementation by the sponsor. Patients will take 1 capsule orally 3 times a day for a full 12 weeks. Sperm DNA structure will be re-assessed after completion of 12 weeks of antioxidant to compare to baseline sperm DNA structure collected prior to starting regimen of supplement daily
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 54
-Sperm Chromatin >16%, sufficient ejaculate sperm for ICSI
- Severe male factor infertility
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment group Natural Antioxidant supplement Male patients exposed to antioxidant for 12 weeks
- Primary Outcome Measures
Name Time Method Sperm DNA fragmentation 12 weeks Direct comparison of sperm DNA fragmentation pre and post natural antioxidant exposure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Colorado Center for Reproductive Medicine
🇺🇸Lone Tree, Colorado, United States