Males, Antioxidants, and Infertility Trial (MOXI)
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ClinicalTrials.gov Identifier: NCT02421887 |
Recruitment Status :
Completed
First Posted : April 21, 2015
Results First Posted : September 4, 2019
Last Update Posted : September 4, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Male Infertility | Drug: Antioxidant Supplement Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 171 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Males, Antioxidants, and Infertility (MOXI) Trial |
Actual Study Start Date : | December 2015 |
Actual Primary Completion Date : | June 11, 2018 |
Actual Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Antioxidant Supplement
Tablet: Vitamin C, 500 mg; Vitamin D3, 1000 IU; Vitamin E, 400 IU; Folic Acid 1000 mcg; Zinc, 20 mg; Selenium 200 mcg; Lycopene, 10 mg; Capsule: Vitamin D3, 1000 IU, L-Carnitine, 1000 mg
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Drug: Antioxidant Supplement
An antioxidant combination including Vitamin C, Vitamin E, folic acid, selenium, zinc, and L-carnitine |
Placebo Comparator: Placebo |
Other: Placebo
Placebo |
- Live Birth Rate [ Time Frame: up to 15 months ]
- Pregnancy Rate [ Time Frame: up to 7 months ]
- Miscarriage Rate [ Time Frame: up to 9 months ]miscarriages per total number of pregnancies
- Time to Pregnancy [ Time Frame: up to 7 months ]Time to pregnancy will be the chronologic time from randomization to pregnancy detection in days, in which the pregnancy is defined as a human Chorionic Gonadotropin (hCG) value over 5 on 2 separate occasions.
- Change in Total Motile Sperm Count [ Time Frame: baseline and 3 months ]Samples will be assessed using a standard semen analysis
- Change in Deoxyribonucleic Acid (DNA) Fragmentation Index (DFI) [ Time Frame: Baseline and 3 months ]DFI is the ratio of damaged sperm to total sperm. It is measured using Sperm Chromatin Structure Analysis (SCSA) which was performed on 5000 sperm per sample.
- Change in Semen Total Motility [ Time Frame: baseline and 3 months ]Samples assessed using a standard semen analysis
- Change in Sperm Concentration [ Time Frame: baseline and 3 months ]Samples assessed using a standard semen analysis
- Change in Normal Morphology of Semen, Using World Health Organization (WHO) 5 Criteria [ Time Frame: baseline and 3 months ]Samples assessed using a standard semen analysis
- Change in Total Sperm Count [ Time Frame: baseline and 3 months ]Samples assessed using a standard semen analysis

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421887
United States, California | |
Keck School of Medicine of University of Southern California | |
Los Angeles, California, United States, 90089 | |
University of California San Francisco | |
San Francisco, California, United States, 94115 | |
Stanford University | |
Sunnyvale, California, United States, 94087 | |
United States, Georgia | |
Augusta University | |
Augusta, Georgia, United States, 30912 | |
United States, Michigan | |
Wayne State University | |
Southfield, Michigan, United States, 48034 | |
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States, 27599 | |
Carolinas Medical Center - Women's Institute | |
Charlotte, North Carolina, United States, 28204 | |
United States, Oklahoma | |
University of Oklahoma | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Pennsylvania | |
Pennsylvania State University | |
Hershey, Pennsylvania, United States, 17033 | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Director: | Esther Eisenberg, MD | Eunice Kennedy Shriver National Institue of Child Health and Human Development | |
Study Chair: | Nanette Santoro, MD | University of Colorado, Denver | |
Principal Investigator: | Anne Z Steiner, MD | University of North Carolina | |
Study Director: | Michael P Diamond, MD | Augusta University | |
Study Director: | Richard S Legro, MD | Penn State University | |
Study Director: | Marcelle Cedars, MD | University of California, San Francisco | |
Study Director: | Karl R Hansen, MD | University of Oklahoma | |
Study Director: | Christos Coutifaris, MD | University of Pennsylvania | |
Study Director: | Heping Zhang, PhD | Yale University |
Documents provided by Yale University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT02421887 |
Other Study ID Numbers: |
MOXI |
First Posted: | April 21, 2015 Key Record Dates |
Results First Posted: | September 4, 2019 |
Last Update Posted: | September 4, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | IPD will be shared with other researchers through the NICHD DASH system. It will be available 6 months after publication of the primary results. |
Time Frame: | Following publication of the primary publication and when the de-identified data have been put into a format that is acceptable for DASH submission. |
Infertility Infertility, Male Antioxidants |
Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |