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Males, Antioxidants, and Infertility Trial (MOXI)

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ClinicalTrials.gov Identifier: NCT02421887
Recruitment Status : Active, not recruiting
First Posted : April 21, 2015
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
University of North Carolina
Augusta University
Penn State University
University of California, San Francisco
University of Oklahoma
University of Pennsylvania
Information provided by (Responsible Party):
Heping Zhang, Yale University

Brief 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.

Condition or disease Intervention/treatment Phase
Male Infertility Drug: Antioxidant Supplement Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 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
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 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
Drug: Antioxidant Supplement
An antioxidant combination including Vitamin C, Vitamin E, folic acid, selenium, zinc, and L-carnitine

Placebo Comparator: Placebo Other: Placebo
Placebo




Primary Outcome Measures :
  1. Live Birth Rate [ Time Frame: up to 15 months ]

Secondary Outcome Measures :
  1. Pregnancy Rate [ Time Frame: up to 7 months ]
  2. Miscarriage Rate [ Time Frame: up to 9 months ]
    miscarriages per total number of pregnancies

  3. 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 an HCG value over 5 on 2 separate occasions.

  4. Change in semen parameters, using WHO 5 criteria [ Time Frame: baseline and 3 months ]
    Samples will be assessed using a standard semen analysis, including assessment of morphology using WHO 5 criteria

  5. Percentage of sperm with fragmented DNA [ Time Frame: 3 months ]
    DNA fragmentation will be measured by TUNEL , SCSA, and Comet assays to determine the percentage of sperm with fragmented DNA.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Yale University
University of North Carolina
Augusta University
Penn State University
University of California, San Francisco
University of Oklahoma
University of Pennsylvania
Investigators
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

Additional Information:
Responsible Party: Heping Zhang, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT02421887     History of Changes
Other Study ID Numbers: MOXI
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
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.

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs