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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.

管理请求项目摘要在美国，368，000个辅助生殖周期中约有75% 每年都有冷冻胚胎。多项研究表明，冷冻胚胎妊娠高血压疾病（如先兆子痫）的风险增加。至关重要的是，这种风险被最大限度地减少，因为先兆子痫与严重的短-和对母亲和婴儿的长期影响。我们需要的是一个严格的，前瞻性的，随机对照试验，接受IVF的女性被随机分配到周期中，黄体（CL）的存在。NatPro由NICHD资助，作为一项关联R 01，随机 2019年9月的临床试验旨在明确回答这个问题：高血压当在CL的自然周期中进行FET时，妊娠疾病减少，当与无CL的程控周期相比？不幸的是，NatPro的推出恰逢 2019冠状病毒病疫情，以及根据政府于2020年3月提出的建议，诊所关闭，导致研究启动和入组延迟。在COVID之后- 19项限制被取消后，NatPro以与其非常相似的速度稳步招募了研究对象。原计划然而，由于这一大流行病造成的最初的、不可预见的征聘延迟，在五年资助期内完成研究将需要加快招生步伐。这一行政补充的目标有两个方面：1）迅速增加学习人数，招聘网站大幅提高招生速度; 2）增加人员，使完成研究，达到计划入组目标。这两项措施将使 NatPro领导“弯曲曲线”，加快招生步伐，完成在资助期内进行研究。及时完成NatPro研究至关重要，重要性，因为与先兆子痫相关的负面健康结果，母亲和孩子，可能会减少本研究的结果和由此产生的程序使用在胚胎移植之前。当研究达到计划入组人数的53%时，如果入组速度，样本量很可能不足以确定对患者和供应商的建议。然而，如果研究完成，研究结果可能会成为临床指南的基础，每年影响368，000名妇女，依靠试管婴儿建立家庭的美国人。