Randomized Controlled Trial: The Effects of Vitamin D Supplementation on In-vitro Fertilization Outcomes
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
- 否
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
Irene Moy
Clinical Fellow
Northwestern University
