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临床试验/NCT01419743
NCT01419743终止不适用

Randomized Controlled Trial: The Effects of Vitamin D Supplementation on In-vitro Fertilization Outcomes

Northwestern University3 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
102
试验地点
3
主要终点
Clinical pregnancy rate

研究概览

简要总结

Historically, vitamin D has been considered to play a role solely in bone and calcium metabolism. Numerous studies have suggested a link between vitamin D deficiency and adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. In the obstetrics literature, vitamin D deficiency has been linked to preeclampsia, gestational diabetes, and increased rate of cesarean section rate. Recent data from retrospective chart reviews have demonstrated a possible role of vitamin D in implantation and clinical pregnancy rates in patients undergoing in-vitro fertilization. Patients found to be deficient in vitamin D were found to have significantly lower clinical pregnancy rates when compared to patients who were replete in vitamin D levels. Currently, there are no prospective clinical trials investigating the effects of vitamin D supplementation on IVF outcomes such as clinical pregnancy rate and implantation rates. The investigators hypothesize that the vitamin D supplementation in patients found to be either deficient or insufficient in vitamin D will lead to improved pregnancy rates in infertility patients undergoing in-vitro fertilization.

详细描述

The trial will not pay for or subsidize for IVF treatment. Participants will receive blood Vitamin D screening test and any necessary supplements free of charge.

研究设计

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

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Infertile women aged ≤ 38 years undergoing fresh invitro fertilization cycles

排除标准

  • Infertile women aged > 38 undergoing fresh invitro fertilization cycles
  • Patients undergoing frozen embryo transfers
  • Patients undergoing donor-egg cycles
  • Patients who have a contraindication to receiving Vitamin D (e.g. patients with history of primary hyperparathyroidism, sarcoidosis, tuberculosis, kidney disease, or lymphoma)

结局指标

主要结局

Clinical pregnancy rate

时间窗: assessed at conclusion of the study (~ 1 yr)

Serum hCG will be drawn per routine IVF protocol (\~ 10 days after embryo transfer). Patients will have a repeat bHCG drawn 48hrs if they have a positive result from the first bHCG test. Clinical pregnancy will be defined as ultrasound documentation of fetal heart tones.

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

Irene Moy

Clinical Fellow

Northwestern University

研究点 (3)

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