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NCT02421887 · ClinicalTrials.gov registry record · Phase 2
Males, Antioxidants, and Infertility Trial
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 171
- Enrollment target
NCT02421887 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 171 participants.
The verdict
NCT02421887, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 171 participants
- Enrollment target
Study Summary
The objective of the Males, Antioxidants, and Infertility (MOXI) Trial is to examine whether treatment of infertile males with an antioxidant formulation improves male fertility. The central hypothesis is that treatment of infertile males with antioxidants will improve sperm structure and function, resulting in higher fertilization rates and improved embryo development, leading to higher pregnancy and live birth rates. Findings from this research will be significant in that they will likely lead to an effective, non-hormonal treatment modality for male infertility. An effective treatment for men would also reduce the treatment burden on the female partner, lower costs, and provide effective alternatives to couples with religious or ethical contraindications to ART (Assisted Reproductive Technology). If antioxidants do not improve pregnancy rates, but do improve sperm motility and DNA integrity, they could allow for couples with male factor infertility to use less intensive therapies such as intrauterine insemination. Male fertility specialists currently prescribe antioxidants based on the limited data supporting their use. A negative finding, lack of any benefit, would also alter current treatment of infertile males.
Interventions
- OTHER Placebo
- DRUG Antioxidant Supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2015-12 |
| Est. Completion | 2018-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02421887
The ClinicalTrials.gov registry entry for NCT02421887 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 171 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02421887 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02421887 about?
NCT02421887 is a clinical study titled "Males, Antioxidants, and Infertility Trial". The objective of the Males, Antioxidants, and Infertility (MOXI) Trial is to examine whether treatment of infertile males with an antioxidant formulation improves male fertility. The central hypothesis is that treatment of infertile males with antioxidants will improve sperm structure and function, ...
What is the current status of trial NCT02421887?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 171 participants. The study started on 2015-12. Estimated completion is 2018-12.
What interventions are being tested in trial NCT02421887?
The interventions under investigation include: Placebo (OTHER), Antioxidant Supplement (DRUG).
Who is sponsoring clinical trial NCT02421887?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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