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Males, Antioxidants, and Infertility Trial (MOXI)

Primary Purpose

Male Infertility

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Antioxidant Supplement

Placebo

About this trial

This is an interventional treatment trial for Male Infertility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Antioxidant Supplement

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Live Birth Rate

Secondary Outcome Measures

Pregnancy Rate

Miscarriage Rate

miscarriages per total number of pregnancies

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.

Change in Total Motile Sperm Count

Samples will be assessed using a standard semen analysis

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.

Change in Semen Total Motility

Samples assessed using a standard semen analysis

Change in Sperm Concentration

Samples assessed using a standard semen analysis

Change in Normal Morphology of Semen, Using World Health Organization (WHO) 5 Criteria

Samples assessed using a standard semen analysis

Change in Total Sperm Count

Samples assessed using a standard semen analysis

Full Information

NCT ID

NCT02421887

First Posted

March 19, 2015

Last Updated

August 12, 2019

Sponsor

Yale University

Collaborators

University of North Carolina, Augusta University, Penn State University, University of California, San Francisco, University of Oklahoma, University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT02421887

Brief Title

Males, Antioxidants, and Infertility Trial

Acronym

MOXI

Official Title

Males, Antioxidants, and Infertility (MOXI) Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

December 2015 (Actual)

Primary Completion Date

June 11, 2018 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

University of North Carolina, Augusta University, Penn State University, University of California, San Francisco, University of Oklahoma, University of Pennsylvania

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Male Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

171 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Antioxidant Supplement

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Antioxidant Supplement

Intervention Description

An antioxidant combination including Vitamin C, Vitamin E, folic acid, selenium, zinc, and L-carnitine

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Live Birth Rate

Time Frame

up to 15 months

Secondary Outcome Measure Information:

Title

Pregnancy Rate

Time Frame

up to 7 months

Title

Miscarriage Rate

Description

miscarriages per total number of pregnancies

Time Frame

up to 9 months

Title

Time to Pregnancy

Description

Time Frame

up to 7 months

Title

Change in Total Motile Sperm Count

Description

Samples will be assessed using a standard semen analysis

Time Frame

baseline and 3 months

Title

Change in Deoxyribonucleic Acid (DNA) Fragmentation Index (DFI)

Description

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.

Time Frame

Baseline and 3 months

Title

Change in Semen Total Motility

Description

Samples assessed using a standard semen analysis

Time Frame

baseline and 3 months

Title

Change in Sperm Concentration

Description

Samples assessed using a standard semen analysis

Time Frame

baseline and 3 months

Title

Change in Normal Morphology of Semen, Using World Health Organization (WHO) 5 Criteria

Description

Samples assessed using a standard semen analysis

Time Frame

baseline and 3 months

Title

Change in Total Sperm Count

Description

Samples assessed using a standard semen analysis

Time Frame

baseline and 3 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 < 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

Overall Study Officials: