MOXI: Males, Antioxidants, and Infertility

  • STATUS
    Recruiting
  • participants needed
    50
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Updated on 19 February 2024

Summary

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.

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.

FAQ

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.

Details
Condition Male Infertility
Age 18years - 100years
Clinical Study IdentifierTX1084
Last Modified on19 February 2024

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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