Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03646825 |
| Other study ID # |
20170532 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2018 |
| Est. completion date |
October 1, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Colorado Center for Reproductive Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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
