Natural vs. programmed cycles for frozen embryo transfer: study protocol for an investigator-initiated, randomized, controlled, multicenter clinical trial.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Cryopreservation* ; Embryo Transfer*; Female ; Humans ; Live Birth ; Multicenter Studies as Topic ; Pregnancy ; Pregnancy Rate ; Randomized Controlled Trials as Topic ; Reproductive Techniques, Assisted ; Retrospective Studies

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.gov NCT04551807 . Registered on September 16, 2020.
(© 2021. The Author(s).)

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R01HD100305 National Institute of Child Health and Human Development; R01 HD100341 United States HD NICHD NIH HHS; R01 HD100305 United States HD NICHD NIH HHS; R01HD100341 National Institute of Child Health and Human Development; R01HD100334 National Institute of Child Health and Human Development

Investigator: L Aghajanova; R Alvero; M Andrews; D Arevalo; E Barnard; A Casillas; M Copeland; TB Craig; KM Doody; A Eskew; A Gonzalez; G Hoelscher; AJ Vaught; L Kochman; A Lears; G Murugappan; AC Nackley; T Newsome; N Quintana; B Singh; A Sokalska; M Starkey-Scruggs; RL Thomas; D Toney; I Trueheart; K Turner; R Usadi; S Villalobos; A Wignarajah; V Winn; C Zones
Keywords: Frozen-thawed embryo transfer; Modified natural cycle; Preeclampsia; Programmed cycle

ClinicalTrials.gov NCT04551807

Date Created: 20210928 Date Completed: 20210929 Latest Revision: 20220716

20231215

PMC8477459

10.1186/s13063-021-05637-3

34579768