Effect of Natural Antioxidant Supplement on Sperm DNA Fragmentation

Colorado Center for Reproductive Medicine

Status: Terminated

Conditions: Observe Effect of Antioxidant on Sperm DNA Fragmention

Treatments: Dietary Supplement: Natural Antioxidant supplement

Study type: Observational

Funder types: Other

Identifiers

NCT03646825

20170532

Details and patient eligibility

About

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.

Full 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

Enrollment: 54 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Sperm Chromatin >16%, sufficient ejaculate sperm for ICSI

Exclusion criteria

• Severe male factor infertility

Trial design

54 participants in 1 patient group

Treatment group

Description:

Male patients exposed to antioxidant for 12 weeks

Treatment:

Dietary Supplement: Natural Antioxidant supplement