Folic Acid and Zinc Supplementation Trial

不孕症影响了10%到15%试图怀孕的夫妇。男性因素低生育力在大约50%的低生育力夫妇中起作用，病因基本未知。即使对男性因素不育的任何组成部分有很小的绝对影响的干预措施，也会在人口水平上产生巨大的影响，因为潜在的可归因效益很大。叶酸和锌这两种对精子发生过程至关重要的微量营养素特别令人感兴趣，因为它们提供了潜在的低成本和广泛可用的治疗方法。虽然证据不一致，但小型随机试验和观察性研究表明，叶酸和锌对精子发生和改善精液参数具有生物学上合理的作用。这些结果支持叶酸对精子发生的潜在益处，并表明补充叶酸和锌可以改善精液质量，也许还可以改善辅助生殖技术（ART）的结果。 这是一项多中心、双盲、随机安慰剂对照试验，旨在评估叶酸和锌膳食补充剂对精液质量的影响，并间接影响2400名寻求辅助生殖的夫妇的男性伴侣的受孕率和妊娠结局。共2，400例男性受试者将被随机平均（1：1）分配至活性研究膳食补充剂（每日叶酸和锌）或匹配的安慰剂组。仅将雄性动物随机分配至研究膳食补充剂或安慰剂组。治疗将持续6个月。筛选访视后，受试者将在基线、2、4和6个月时返回。该试验于2017年12月完成招募，随访持续到2018年，并于2019年进行数据分析。审判结果待定。

Infertility affects 10 to 15% of couples attempting to conceive. Male factor subfertility plays a role in about 50% of subfertile couples, with largely unknown etiology. An intervention with even a small absolute effect on any component of male factor infertility has tremendous implications at the population level because of the large potential attributable benefit. Two micronutrients fundamental to the process of spermatogenesis, folate and zinc, are of particular interest as they offer a potential low cost and widely available treatment. Though the evidence has been inconsistent, small randomized trials and observational studies show that folate and zinc have biologically plausible effects on spermatogenesis and improved semen parameters. These results support the potential benefits of folate on spermatogenesis, and suggest that supplementation with folate and zinc may improve semen quality, and perhaps, assisted reproductive technology (ART) outcomes. This is a multi-center, double-blind, randomized placebo-controlled trial to assess the effects of folic acid and zinc dietary supplementation on semen quality , and indirectly on conception rates and pregnancy outcomes among 2400 male partners of couples seeking assisted reproduction. A total of 2,400 male participants will be randomized equally (1:1) either to active study dietary supplements (folic acid and zinc daily) or to matching placebo. Only the males will be randomized to study dietary supplement or placebo. Treatment will continue for 6 months. Following a screening visit, participants will return at baseline, 2, 4, and 6 months. The trial completed recruitment in December 2017, with follow-up continuing through 2018, and data analysis in 2019. The trial results are pending.