NCT02421887.

Trial name or title	Males, antioxidants, and infertility trial (MOXI)
Methods	Interventional (Clinical Trial) Design Allocation: randomised Intervention model: parallel assignment Masking: triple (participant, care provider, investigator)
Participants	Males, 18 years and older Inclusion criteria Couple 12 or more months of infertility (primary or secondary) Heterosexual Cohabitating and able to have regular intercourse Male ≥ 18 years of age At least one abnormal semen parameter on a semen analysis within the past 6 months: sperm concentration ≤15 Million/mL, total motility ≤ 40% normal morphology (Kruger) ≤ 4%DNA fragmentation (SCSA, DNA fragmentation index) >25% Female ‐ ≥18 years of age and ≤40 years of age ‐ For women ≥ 35 years of age, evidence of normal ovarian reserve as assessed by menstrual cycle day 3 (+/‐2 days) FSH ≤10 IU/L with estradiol 70 pg/mL, AMH ≥ 1.0 ng/mL, OR antral follicle count >10 within one year prior to study initiation Evidence of at least one patent fallopian tube as determined by an hysterosalpingogram or laparoscopy showing at least one patent fallopian tube or a saline infusion sonogram showing spillage of contrast material Regular cycles defined as ≥25 days and ≤ 35 days in duration Evidence of ovulation including biphasic basal body temperatures, positive ovulation predictor kits, or progesterone level ≥3 ng/mL Regular cycles defined as ≥25 days and ≤ 35 days in duration Evidence of ovulation including biphasic basal body temperatures, positive ovulation predictor kits, or progesterone level ≥3 ng/mL Evidence of ovulation including biphasic basal body temperatures, positive ovulation predictor kits, or progesterone level ≥3 ng/mL Exclusion criteria Couple Previous sterilisation procedures (vasectomy, tubal ligation); the prior procedure may affect study outcomes Planning in vitro fertilisation in the next 6 months Male Sperm concentration < 5 million/mL on screening semen analysis Current use of a medication or drug that would affect reproductive function or metabolism (see Appendix C for list) Current multivitamin or herb use (requires 1 month wash‐out) Current serious medical illnesses, such as cancer, heart disease, or cirrhosis Current use of anticoagulants Untreated hypothyroidism Uncontrolled diabetes mellitus Female History of surgically or medically confirmed moderate or severe endometriosis Body mass index >35 kg/m2 Currently pregnant History of polycystic ovarian syndrome Current serious medical illnesses, such as cancer, heart disease, or cirrhosis History of systemic chemotherapy or pelvic radiation Current use of a medication or drug that would affect reproductive function or metabolism
Interventions	Drug: antioxidant supplement Ingredients: Vitamin C, 500 mg; Vitamin D3, 1000 IU; Vitamin E, 400 IU; Folic Acid 1000 mcg; Zinc, 20 mg; Selenium 200 mcg; Lycopene, 10 mg; Capsule: Vitamin D3, 1000 IU, L‐Carnitine, 1000 mg Control: placebo
Outcomes	Primary Live birth rate Secondary Pregnancy rate Miscarriage rate Time to pregnancy Change in semen parameters, using WHO 5 criteria Percentage of sperm with fragmented DNA
Starting date	December 2015
Contact information	Anne Z Steiner, MD University of North Carolina Heping Zhang, Principal Investigator, Yale University
Notes	Still recruiting according to the Yale/Stanford site/Penn Medicine sites, February 2018