Males, Antioxidants, and Infertility Trial

Male Infertility Clinical Trial

— MOXI  

Official title:

Males, Antioxidants, and Infertility (MOXI) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421887
• Other study ID #: MOXI
• Status: Completed
• Phase: Phase 2
• Start date: December 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: December 2018
• Est. primary completion date: June 11, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Drug:
• Antioxidant Supplement
An antioxidant combination including Vitamin C, Vitamin E, folic acid, selenium, zinc, and L-carnitine

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Carolinas Medical Center - Women's Institute	Charlotte	North Carolina
United States	Pennsylvania State University	Hershey	Pennsylvania
United States	Keck School of Medicine of University of Southern California	Los Angeles	California
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of California San Francisco	San Francisco	California
United States	Wayne State University	Southfield	Michigan
United States	Stanford University	Sunnyvale	California

Sponsors (7)

Lead Sponsor	Collaborator
Yale University	Augusta University, Penn State University, University of California, San Francisco, University of North Carolina, University of Oklahoma, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live Birth Rate		up to 15 months
Secondary	Pregnancy Rate		up to 7 months
Secondary	Miscarriage Rate	miscarriages per total number of pregnancies	up to 9 months
Secondary	Time to Pregnancy	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.	up to 7 months
Secondary	Change in Total Motile Sperm Count	Samples will be assessed using a standard semen analysis	baseline and 3 months
Secondary	Change in Deoxyribonucleic Acid (DNA) Fragmentation Index (DFI)	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.	Baseline and 3 months
Secondary	Change in Semen Total Motility	Samples assessed using a standard semen analysis	baseline and 3 months
Secondary	Change in Sperm Concentration	Samples assessed using a standard semen analysis	baseline and 3 months
Secondary	Change in Normal Morphology of Semen, Using World Health Organization (WHO) 5 Criteria	Samples assessed using a standard semen analysis	baseline and 3 months
Secondary	Change in Total Sperm Count	Samples assessed using a standard semen analysis	baseline and 3 months

External Links

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