MOXI: Males, Antioxidants, and Infertility
Brief Description Of Study
MOXI is a research study to examine whether antioxidants can improve abnormal semen parameters in couples with male-factor infertility. Eligible male participants will be randomized to either an antioxidant supplement or placebo for 3 months, followed by fertility treatment with ovarian stimulation and intrauterine insemination.
Detailed Study Description
MOXI Phase I will involve randomization to either an antioxidant supplement or placebo. This study is blinded, such that neither the participant nor the study team will know which treatment is assigned. After 3 months of treatment (with the assigned study drug), couples will be receive up to 3 consecutive cycles of female ovarian stimulation with an oral medication (clomiphene citrate), triggered ovulation with hCG, and a single intrauterine insemination (Phase II). Couples who conceive in either Phase I or Phase II will be followed through pregnancy and delivery. Male subjects will take their assigned study drug for at least 3 and up to 6 months.
Additional Information About The Study
Study subjects will be adult men in good health with at least 1 abnormal parameter on a semen analysis. Subjects must have a female partner with regular periods, normal ovulatory function, at least one patent fallopian tube, and normal uterine cavity. Eligibility will be determined by the research team during a screening phase, prior to randomization and Phase I. Most study related mediations, tests, and interventions will be provided, at no costs.