Males, Antioxidants, and Infertility (MOXI) Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 10
- 主要终点
- Live Birth Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •12 or more months of infertility (primary or secondary)
- •Heterosexual
- •Cohabitating and able to have regular intercourse
- •≥ 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%
- •≥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.
排除标准
- •Previous sterilization procedures (vasectomy, tubal ligation). The prior procedure may affect study outcomes.
- •Planning in vitro fertilization in the next 6 months
- •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
- •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
研究组 & 干预措施
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
干预措施: Antioxidant Supplement (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Live Birth Rate
时间窗: up to 15 months
次要结局
- Pregnancy Rate(up to 7 months)
- Miscarriage Rate(up to 9 months)
- Time to Pregnancy(up to 7 months)
- Change in Total Motile Sperm Count(baseline and 3 months)
- Change in Semen Total Motility(baseline and 3 months)
- Change in Deoxyribonucleic Acid (DNA) Fragmentation Index (DFI)(Baseline and 3 months)
- Change in Sperm Concentration(baseline and 3 months)
- Change in Normal Morphology of Semen, Using World Health Organization (WHO) 5 Criteria(baseline and 3 months)
- Change in Total Sperm Count(baseline and 3 months)