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Summary

for males ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

Males, Antioxidants, and Infertility (MOXI) Trial

Keywords

Male Infertility Infertility Infertility, Male Antioxidants

Eligibility

You can join if…

Open to males ages 18 years and up

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.

You CAN'T join if...

  • 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

Locations

  • University of California San Francisco
    San Francisco, California, 94115, United States
  • Stanford University
    Sunnyvale, California, 94087, United States
  • Keck School of Medicine of University of Southern California
    Los Angeles, California, 90089, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Yale University
Links
http://c2s2.yale.edu/rmn/
ID
NCT02421887
Phase
Phase 2
Lead Scientist
Study Type
Interventional
Last Updated
September 28, 2017