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，进行了 368,000 次辅助生殖周期中的大约 75% 每年都涉及冷冻胚胎。多项研究表明冷冻胚胎之间存在关联。转移（FET）会增加妊娠期高血压疾病（如先兆子痫）的风险。将这种风险降至最低至关重要，因为先兆子痫与严重的短期和对母亲和婴儿的长期影响需要的是严格的、前瞻性的、随机对照试验，接受体外受精的女性被随机分配到有或没有的周期黄体 (CL) 的存在由 NICHD 作为关联 R01 资助，随机。 2019 年 9 月的临床试验旨在明确回答以下问题：是否患有高血压当 FET 在自然周期中与 CL 一起进行时，妊娠疾病会减少与没有 CL 的编程周期相比？不幸的是，NatPro 的推出恰逢 COVID-19 大流行，并根据 2020 年 3 月政府的建议，IVF 新冠疫情爆发后，诊所被关闭，导致研究的启动和招募被推迟。 19 项限制被取消，NatPro 稳步招募研究对象，其速度与其非常相似然而，由于疫情导致最初的、不可预见的招聘延迟，在五年资助期内完成研究将需要加快入学速度。该行政补充的目标有两个：1）迅速增加研究数量招聘网站大幅提高招生速度；2）增加人员以启用这两项措施将共同完成研究并达到计划的入学目标。 NatPro 领导层“弯曲曲线”并加快招生步伐并完成在资助期限内及时完成 NatPro 研究是最重要的。重要性，因为与先兆子痫相关的负面健康结果影响着双方本研究的结果和所使用的结果程序可能会最大限度地减少母亲和孩子的痛苦在胚胎移植之前，如果研究没有变化，则研究进度为计划入组人数的 53%。招生速度，样本量很可能不足以做出明确的结论然而，如果研究完成，则对患者和提供者的建议。研究结果可能会成为每年影响 368,000 名女性的临床指南的基础依靠试管受精来建立家庭的美国。