Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) Outcomes
2014年2月16日 更新者:Irene Moy、Northwestern University
Randomized Controlled Trial: The Effects of Vitamin D Supplementation on In-vitro Fertilization Outcomes
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (预期的)
102
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern Memorial Hospital
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Chicago、Illinois、美国、60611
- Northwestern University Feinberg School of Medicine
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Chicago、Illinois、美国、60611
- Northwestern Memorial Faculty Foundation
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 38年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Infertile women aged ≤ 38 years undergoing fresh in-vitro fertilization cycles
描述
Inclusion Criteria:
- Infertile women aged ≤ 38 years undergoing fresh invitro fertilization cycles
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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patients with Vit D level of < 20ng/mL: Group 1
randomized to receive 400 IU of vitamin D per day
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patients with Vit D levels <20ng/mL: Group 2
Randomized to receive 2000IU of Vitamin D per day
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patients with vit D levels between 20-30 ng/mL: Group 3
Randomized to receiving placebo
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patients with vit D levels between 20-30 ng/mL: Group 4
Randomized to receive 400IU of vitamin D per day
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patients with vit D levels between 20-30 ng/mL: Group 5
Randomized to receive 2000IU of vitamin D per day
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patients with vit D levels > 30ng/mL: Group 6
No treatment
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Clinical pregnancy rate
大体时间:assessed at conclusion of the study (~ 1 yr)
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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.
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assessed at conclusion of the study (~ 1 yr)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Ralph Kazer, MD、Northwestern Memorial Faculty Foundation
- 学习椅:Irene Moy, MD、Northwestern University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
- Ozkan S, Jindal S, Greenseid K, Shu J, Zeitlian G, Hickmon C, Pal L. Replete vitamin D stores predict reproductive success following in vitro fertilization. Fertil Steril. 2010 Sep;94(4):1314-1319. doi: 10.1016/j.fertnstert.2009.05.019. Epub 2009 Jul 8.
- Bodnar LM, Catov JM, Simhan HN, Holick MF, Powers RW, Roberts JM. Maternal vitamin D deficiency increases the risk of preeclampsia. J Clin Endocrinol Metab. 2007 Sep;92(9):3517-22. doi: 10.1210/jc.2007-0718. Epub 2007 May 29.
- Dobnig H, Pilz S, Scharnagl H, Renner W, Seelhorst U, Wellnitz B, Kinkeldei J, Boehm BO, Weihrauch G, Maerz W. Independent association of low serum 25-hydroxyvitamin d and 1,25-dihydroxyvitamin d levels with all-cause and cardiovascular mortality. Arch Intern Med. 2008 Jun 23;168(12):1340-9. doi: 10.1001/archinte.168.12.1340.
- Pittas AG, Lau J, Hu FB, Dawson-Hughes B. The role of vitamin D and calcium in type 2 diabetes. A systematic review and meta-analysis. J Clin Endocrinol Metab. 2007 Jun;92(6):2017-29. doi: 10.1210/jc.2007-0298. Epub 2007 Mar 27.
- Barrett H, McElduff A. Vitamin D and pregnancy: An old problem revisited. Best Pract Res Clin Endocrinol Metab. 2010 Aug;24(4):527-39. doi: 10.1016/j.beem.2010.05.010.
- Heaney RP. Vitamin D in health and disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1535-41. doi: 10.2215/CJN.01160308. Epub 2008 Jun 4.
- Johnson LE, DeLuca HF. Reproductive defects are corrected in vitamin d-deficient female rats fed a high calcium, phosphorus and lactose diet. J Nutr. 2002 Aug;132(8):2270-3. doi: 10.1093/jn/132.8.2270.
- Kinuta K, Tanaka H, Moriwake T, Aya K, Kato S, Seino Y. Vitamin D is an important factor in estrogen biosynthesis of both female and male gonads. Endocrinology. 2000 Apr;141(4):1317-24. doi: 10.1210/endo.141.4.7403.
- Halloran BP, DeLuca HF. Effect of vitamin D deficiency on fertility and reproductive capacity in the female rat. J Nutr. 1980 Aug;110(8):1573-80. doi: 10.1093/jn/110.8.1573.
- Trivedi DP, Doll R, Khaw KT. Effect of four monthly oral vitamin D3 (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: randomised double blind controlled trial. BMJ. 2003 Mar 1;326(7387):469. doi: 10.1136/bmj.326.7387.469.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年8月1日
初级完成 (实际的)
2014年1月1日
研究完成 (实际的)
2014年1月1日
研究注册日期
首次提交
2011年8月16日
首先提交符合 QC 标准的
2011年8月17日
首次发布 (估计)
2011年8月18日
研究记录更新
最后更新发布 (估计)
2014年2月19日
上次提交的符合 QC 标准的更新
2014年2月16日
最后验证
2014年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.