Phase 2
N=171
Males, Antioxidants, and Infertility Trial
Male Infertility
Bottom Line
View on ClinicalTrials.gov: NCT02421887 ↗Enrolled (actual)
171
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Live Birth Rate — 15.3; 22.1 percentage of live births
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Antioxidant Supplement (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Yale University
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Live Birth Rate |
15.3; 22.1 | — |
| SECONDARY Pregnancy Rate |
18; 26 | — |
| SECONDARY Miscarriage Rate |
4; 5 | — |
| SECONDARY Time to Pregnancy |
103.5; 123.5 | — |
| SECONDARY Change in Total Motile Sperm Count |
-4.0; 1.5 | — |
| SECONDARY Change in Deoxyribonucleic Acid (DNA) Fragmentation Index (DFI) |
18.7; 21.1 | — |
| SECONDARY Change in Semen Total Motility |
-1.6; -1.1 | — |
| SECONDARY Change in Sperm Concentration |
-4.0; 2.4 | — |
| SECONDARY Change in Normal Morphology of Semen, Using World Health Organization (WHO) 5 Criteria |
0; 0 | — |
| SECONDARY Change in Total Sperm Count |
-10.6; 1.6 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT02421887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.