1/3 A randomized controlled trial of frozen embryo transfers performed in modified natural versus programmed cycles (NatPro)

1/3 以改良的自然周期与程序周期进行冷冻胚胎移植的随机对照试验 (NatPro)

基本信息

批准号：
10846307
负责人：
Valerie Lynn Baker
金额：
$ 120.38万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-26 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10846307
关键词：
Acceleration Administrative Supplement Affect Black race COVID-19 COVID-19 pandemic Caring Child Clinic Clinical Collection Data Development Embryo Embryo Transfer Enrollment Family Fertility Fertilization in Vitro Fetal Death Fetal Growth Retardation Funding Future Goals Government Guidelines Health Human Resources Hypertension Infant Leadership Lifting Link Maternal Mortality Measures Mothers National Institute of Child Health and Human Development Observational Study Outcome Participant Patients Pre-Eclampsia Pregnancy Pregnancy Outcome Procedures Provider Randomized Randomized, Controlled Trials Recommendation Reporting Research Risk Sample Size Site Study Subject Time United States Woman assisted reproduction clinical research site coronavirus disease corpus luteum design embryo cryopreservation pandemic disease pregnancy disorder prospective randomized, clinical trials recruit risk minimization

项目摘要

Administrative Request Project Summary In the United States, approximately 75% of the 368,000 assisted reproduction cycles performed annually involve frozen embryos. Multiple studies have suggested an association of frozen embryo transfer (FET) with an increased risk of hypertensive disorders of pregnancy, such as preeclampsia. It is critical that this risk be minimized because preeclampsia is associated with severe short- and long-term consequences for both mother and infant. What is needed is a rigorous, prospective, randomized controlled trial where women undergoing IVF are randomized to cycles with and without the presence of a corpus luteum (CL). NatPro was funded by NICHD as a linked R01, randomized clinical trial in September 2019 designed to definitively answer the question: are hypertensive disorders of pregnancy reduced when FETs are performed in a natural cycle with a CL, when compared to a programmed cycle without a CL? Unfortunately, the launch of NatPro coincided with the COVID-19 pandemic and, in accordance with government recommendations in March 2020, IVF clinics were shutdown leading to a delay in initiation and enrollment for the study. After the COVID- 19 restrictions were lifted, NatPro has steadily enrolled study subjects at a rate very similar to its original plan. However, due to the initial, unforeseen recruitment delay caused by the pandemic, completion of the study within the 5-year funding period will require an increased pace of enrollment. The goals of this administrative supplement are two-fold: 1) to rapidly increase the number of study recruitment sites to substantially increase the enrollment pace; and 2) to increase personnel to enable completion of the study with the planned enrollment targets. Together, these two measures will allow the NatPro leadership to “bend the curve” and accelerate the pace of enrollment and complete the study within the funding period. Completing the NatPro Study in a timely manner is of the utmost importance because the negative health outcomes associated with preeclampsia, affecting both mother and child, may be minimized by the findings of this study and the resulting procedures used prior to embryo transfer. While the study is at 53% of planned enrollment, if there is no change in the pace of enrollment, the sample size is very likely to be insufficient to make definitive recommendations for patients and providers. If the study is carried to completion, however, the findings are likely to form the basis for clinical guidelines affecting the 368,000 women each year in the US that rely on IVF to build their families.

行政请求项目摘要在美国，在执行的368,000个辅助繁殖周期中，约有75％获取冷冻胚胎的一种方法。多项研究表明冷冻胚胎的关联转移（FET）患有高血压疾病的风险增加，例如先兆子痫。至关重要的是，由于先兆子痫与严重的短期和严重的短期和母亲和婴儿的长期后果。需要的是严格，潜在的，随机对照试验，其中有IVF的妇女被随机分配给有或没有的周期 Luteum（Cl）的存在。 NATPRO由NICHD资助为链接的R01，随机 2019年9月的临床试验旨在明确回答以下问题：高血压当用CL自然循环进行FET时，妊娠疾病降低了，与没有CL的编程周期相比？不幸的是，NATPRO的发布与 19020年3月的政府建议，IVF 诊所被关闭，导致该研究的启动和入学率延迟。在covid-之后解除了19个限制，NATPRO以与其非常相似的速度悄悄地招募了研究对象原始计划。但是，由于大流行造成的最初，不可预见的招聘延迟，在5年资金期内完成研究的完成将需要增加入学空间。这种行政补充的目标有两个方面：1）快速增加研究数量招聘站点大大提高了入学速度； 2）增加人员以启用通过计划的入学目标完成研究。这两个措施在一起将允许 NATPRO领导人“弯曲曲线”并加速入学空间，并完成在资金期内学习。及时完成NATPRO研究是最大的重要的是，因为与先兆子痫相关的负面健康结果，两者都会影响本研究的发现和所使用的程序可以最大程度地减少母子在胚胎转移之前。虽然这项研究是计划入学人数的53％，但如果没有变化入学空间，样本量很可能不足以使确定性针对患者和提供者的建议。但是，如果将研究进行完成，则调查结果可能构成了影响每年368,000名女性的临床准则的基础依靠IVF来建立家人的美国。