Natural vs. programmed cycles for frozen embryo transfer: study protocol for an investigator-initiated, randomized, controlled, multicenter clinical trial.
Natural vs. programmed cycles for frozen embryo transfer: study protocol for an investigator-initiated, randomized, controlled, multicenter clinical trial.
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DOI：
10.1186/s13063-021-05637-3
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发表时间：
2021-09-27
期刊：
影响因子：
2.5
通讯作者：
NatPro Study Group
中科院分区：
文献类型：
--
作者：
Baksh S;Casper A;Christianson MS;Devine K;Doody KJ;Ehrhardt S;Hansen KR;Lathi RB;Timbo F;Usadi R;Vitek W;Shade DM;Segars J;Baker VL;NatPro Study Group
辅助生殖技术（ART）的随机试验是针对临床妊娠或活产的结果而设计的，但尚未为先兆子痫等产科结果提供动力，而先兆子痫对孕产妇和胎儿的健康至关重要。 ART 越来越多地涉及冷冻胚胎移植 (FET)。尽管 FET 有优点，但多项研究表明，与新鲜胚胎移植相比，FET 发生先兆子痫的风险增加，且造成这种差异的原因尚不清楚。 NatPro 将比较两种常用的 FET 方案（改良自然周期和程序周期）之间的先兆子痫比例。在这项双组、平行组、多中心随机试验中，NatPro 将随机将 788 名女性随机分配到改良自然 FET 组或编程 FET 组，并跟踪她们最多三个 FET 周期。主要结果将是分配至改良自然周期 FET（黄体存在）方案的可存活妊娠妇女中先兆子痫的比例与分配至程序化 FET（黄体缺失）方案的孕妇中先兆子痫的比例。次要结局将比较方案之间的活产比例和具有严重特征的先兆子痫的比例。这项研究对数百万追求 ART 来建立家庭的女性具有潜在的重大影响。 NatPro 旨在提供临床相关指导，通过编程和修改的自然循环 FET 方案告知患者和临床医生有关孕产妇风险的信息。这项研究还将通过编程和修改的自然周期 FET 提供有关活产可能性的准确点估计。临床试验.govNCT04551807。注册日期：2020 年 9 月 16 日 在线版本包含可在 10.1186/s13063-021-05637-3 获取的补充材料。
Randomized trials of assisted reproductive technology (ART) have been designed for outcomes of clinical pregnancy or live birth and have not been powered for obstetric outcomes such as preeclampsia, critical for maternal and fetal health. ART increasingly involves frozen embryo transfer (FET). Although there are advantages of FET, multiple studies have shown that risk of preeclampsia is increased with FET compared with fresh embryo transfer, and the reason for this difference is not clear. NatPro will compare the proportion of preeclampsia between two commonly used protocols for FET,modified natural and programmed cycle. In this two-arm, parallel-group, multi-center randomized trial, NatPro will randomize 788 women to either modified natural or programmed FET and follow them for up to three FET cycles. Primary outcome will be the proportion of preeclampsia in women with a viable pregnancy assigned to a modified natural cycle FET (corpus luteum present) protocol compared to the proportion of preeclampsia in pregnant women assigned to a programmed FET (corpus luteum absent) protocol. Secondary outcomes will compare the proportion of live births and the proportion of preeclampsia with severe features between the protocols. This study has a potential significant impact on millions of women who pursue ART to build their families. NatPro is designed to provide clinically relevant guidance to inform patients and clinicians regarding maternal risk with programmed and modified natural cycle FET protocols. This study will also provide accurate point estimates regarding the likelihood of live birth with programmed and modified natural cycle FET. ClinicalTrials.govNCT04551807. Registered on September 16, 2020 The online version contains supplementary material available at 10.1186/s13063-021-05637-3.
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DOI：
10.1093/humrep/dey281
发表时间：
2018-10-01
期刊：
Human reproduction (Oxford, England)
影响因子：
--
作者：
Liu KE;Hartman M;Hartman A;Luo ZC;Mahutte N
通讯作者：
Mahutte N
影响因子：
4
作者：
Makhijani, Reeva;Bartels, Chantal;Engmann, Lawrence
通讯作者：
Engmann, Lawrence
影响因子：
6.7
作者：
Schoolcraft, William B.
通讯作者：
Schoolcraft, William B.
影响因子：
2.5
作者：
Bokslag, Anouk;van Weissenbruch, Mirjam;de Groot, Christianne J. M.
通讯作者：
de Groot, Christianne J. M.
影响因子：
6.1
作者：
Opdahl, S.;Henningsen, A. A.;Romundstad, L. B.
通讯作者：
Romundstad, L. B.