Males, Antioxidants, and Infertility Trial

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.

Exclusion criteria

• Couple:

• Previous sterilization procedures (vasectomy, tubal ligation). The prior procedure may affect study outcomes.
• Planning in vitro fertilization 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