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.

Clinical Study Identifier: TX1084

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.

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To: Research Study Investigator
Subject: I am interested in participating in your Research Study
Dear Investigator,
I'm interested in learning more about and participating in your research study named: MOXI: Males, Antioxidants, and Infertility
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