跳至主要内容
临床试验/NCT03804294
NCT03804294Unknown不适用

Effect of Vitamin D on Outcome of Assisted Reproductive Technology(ART)

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2018年11月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
4,000
试验地点
1
主要终点
clinical pregnancy rates

研究概览

简要总结

Vitamin D has many biological functions. Vitamin D receptors are widely distributed in the male and female reproductive system. Animal experiments have shown that vitamin D deficiency can affect hormone synthesis and gamete formation, reduce sperm motility, and may be related to diseases such as PCOS and endometriosis. Population studies suggest that vitamin D may be related to androgen levels and sperm quality, but whether vitamin D affects the outcome of assisted reproduction is controversial and inconclusive. This study intends to explore whether vitamin D affects the outcome of assisted reproduction through a large sample cohort study.

详细描述

Vitamin D plays an important role in reproduction, while there is high prevalence of vitamin D deficiency. Serum 25(OH)D was categorized according to clinically accepted ranges for vitamin D deficiency (<20 ng/mL), insufficiency (20-30 ng/mL), and replete (>30 ng/mL).

This is a retrospective cohort study of about 2000 infertile couples who undergo their first IVF/ICSI and IUI cycle at Reproductive Medicine Center of Peking University Third Hospital. Patients will be excluded if they refuse to be recruited. Serum samples are collected the day when patients first time to Reproductive Medicine Center and were stored at -20℃ until assayed. Life style of patients is collected by questionair. Vitamin D status is measured by assessing circulating levels of 25(OH)D in frozen, never previously thawed serum samples using radioimmunoassay.

The investigators will comapere the ART outcomes in different groups according to serum 25(OH)D status.

In female, the primary outcome is clinical pregnancy rates defined as the presence of an intrauterinesac with an embryonic pole demonstrating cardiacactivity at 7 weeks of gestation. Secondary outcomes are quality of embryo, positive hCG rates and live birth rates.

In male, the primary outcome is semen quality, such as semen volume, sperm concentration, sperm motility, morphologically normal percent and progressive motile spermatozoa percent. Secondary outcomes are clinical pregnancy rates and live birth rates.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • infertile couples who undergo their first IVF/ICSI and IUI cycle at Reproductive Medicine Center of Peking University Third Hospital.

排除标准

  • refusing to be recruited.

结局指标

主要结局

clinical pregnancy rates

时间窗: 12 weeks after transplantation

Time Frame: the presence of an intrauterinesac with an embryonic pole demonstrating cardiacactivity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhi Xu

associate professor

Peking University Third Hospital

研究点 (1)

Loading locations...

相似试验

Effect of Vitamin D on Outcome of Assisted... | 临床试验