@article{1ccbf3f2a362430ab4ab6d3a761cea4a,
title = "Natural vs. programmed cycles for frozen embryo transfer: study protocol for an investigator-initiated, randomized, controlled, multicenter clinical trial",
abstract = "Background: 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. Methods: 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. Conclusion: 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. Trial registration: ClinicalTrials.govNCT04551807. Registered on September 16, 2020",
keywords = "Frozen-thawed embryo transfer, Modified natural cycle, Preeclampsia, Programmed cycle",
author = "{NatPro Study Group} and Sheriza Baksh and Anne Casper and Christianson, {Mindy S.} and Kate Devine and Doody, {Kevin J.} and Stephan Ehrhardt and Hansen, {Karl R.} and Lathi, {Ruth B.} and Fatmata Timbo and Rebecca Usadi and Wendy Vitek and Shade, {David M.} and James Segars and Baker, {Valerie L.} and Lusine Aghajanova and Ruben Alvero and Mary Andrews and Diego Arevalo and Emily Barnard and Aracely Casillas and Morgan Copeland and Craig, {La Tasha B.} and Doody, {Kathleen M.} and Ashley Eskew and Alma Gonzalez and Gretchen Hoelscher and Vaught, {Arthur Jason} and Lynda Kochman and Andie Lears and Gaya Murugappan and Nackley, {Anna C.} and Tasha Newsome and Natalie Quintana and Bhuchitra Singh and Anna Sokalska and Michelle Starkey-Scruggs and Thomas, {Robin L.} and Deveine Toney and Irene Trueheart and Kisha Turner and Sally Villalobos and Anjali Wignarajah and Virginia Winn and Christy Zones",
note = "Funding Information: NatPro would like to acknowledge our patients and their families as well as our recruitment centers across the USA. NatPro Research Group: Lusine Aghajanova, MD, Ruben Alvero, MD, Mary Andrews, Diego Arevalo, Emily Barnard, Aracely Casillas, RMA, Morgan Copeland, PA-C, LaTasha B. Craig, MD, Kathleen M. Doody, MD, Ashley Eskew, Alma Gonzalez, MPH, LCRC, Gretchen Hoelscher, Arthur Jason Vaught, MD, Lynda Kochman, RN, CCRC, ACRP-PM, Andie Lears, Gaya Murugappan, MD, Anna C. Nackley, MD, Tasha Newsome, Natalie Quintana, Bhuchitra Singh, MD, Anna Sokalska, MD, Michelle Starkey-Scruggs, RN, BSN, Robin L. Thomas, MD, Deveine Toney, RN, Irene Trueheart, RN, Kisha Turner, RN, Rebecca Usadi, MD, Sally Villalobos, Anjali Wignarajah, Virginia Winn, MD, and Christy Zones. Funding Information: NatPro is funded by the National Institutes of Health/National Institute of Child Health and Human Development. The NatPro protocol has been reviewed and approved by the single institutional review board at The Johns Hopkins University School of Medicine. Study monitoring will be conducted by an investigator-appointed data and safety monitoring board (DSMB). The DSMB will monitor the conduct of the trial and make appropriate recommendations to the NatPro Steering Committee regarding the continuation of the trial, safety concerns for study participants, and trial conduct. Publisher Copyright: {\textcopyright} 2021, The Author(s).",
year = "2021",
month = dec,
doi = "10.1186/s13063-021-05637-3",
language = "English (US)",
volume = "22",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",
}