改良自然周期冻融胚胎移植（mNC-FET）中即刻与延迟单囊胚移植的比较：一项多中心随机对照试验研究方案。

Immediate versus postponed single blastocyst transfer in modified natural cycle frozen embryo transfer (mNC-FET): a study protocol for a multicentre randomised controlled trial.

机构信息

Fertility Department 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

Fertility Department 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

出版信息

BMJ Open. 2021 Oct 27;11(10):e053234. doi: 10.1136/bmjopen-2021-053234.

DOI:10.1136/bmjopen-2021-053234

PMID:34706963

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8552140/

Abstract

INTRODUCTION

Today, it is widespread practice to postpone frozen embryo transfer (FET) in a modified natural cycle (mNC) for at least one menstrual cycle after oocyte retrieval and failed fresh embryo transfer or freeze-all. The rationale behind this practice is the concern that suboptimal ovarian, endometrial or endocrinological conditions following ovarian stimulation may have a negative impact on endometrial receptivity and implantation. However, two recent systematic reviews and meta-analyses based on retrospective data did not support this practice. As unnecessary delay in time to transfer and pregnancy should be avoided, the aim of this study is to investigate if immediate single blastocyst transfer in mNC-FET is non-inferior to standard postponed single blastocyst transfer in mNC-FET in terms of live birth rate.

METHODS AND ANALYSIS

Multicentre randomised controlled non-blinded trial including 464 normo-ovulatory women aged 18-40 years undergoing single blastocyst mNC-FET after a failed fresh or freeze-all cycle. Participants are randomised 1:1 to either FET in the first menstrual cycle following the stimulated cycle (immediate FET) or FET in the second or subsequent cycle following the stimulated cycle (postponed FET). The study is designed as a non-inferiority trial and primary analyses will be performed as intention to treat and per protocol.

ETHICS AND DISSEMINATION

Ethical approval has been granted by the Scientific Ethical Committee of the Capital Region of Denmark (J-nr.: H-19086300). Data will be handled according to Danish law on personal data protection in accordance with the general data protection regulation. Participants will complete written consent forms regarding participation in the study and storage of blood samples in a biobank for future research. The study will be monitored by a Good Clinical Practice (GCP)-trained study nurse not otherwise involved in the study. The results of this study will be disseminated by publication in international peer-reviewed scientific journals.

TRIAL REGISTRATION NUMBER

NCT04748874; Pre-results.

摘要

介绍

如今，在取卵后新鲜胚胎移植失败或全胚冷冻后，人们普遍倾向于将冻融胚胎移植（FET）推迟到至少一个修改后的自然周期（mNC）的月经周期。这种做法的理论依据是，取卵后卵巢、子宫内膜或内分泌状况不佳可能会对子宫内膜容受性和着床产生负面影响。然而，最近基于回顾性数据的两项系统评价和荟萃分析并不支持这种做法。由于应避免不必要的延迟时间和妊娠，因此本研究旨在探究 mNC-FET 中即刻单囊胚移植是否不劣于 mNC-FET 中标准延迟单囊胚移植的活产率。

方法和分析

本研究为多中心随机对照非盲试验，纳入了 464 名年龄在 18-40 岁之间的自然排卵正常的女性，这些女性在新鲜周期或全胚冷冻周期失败后进行 mNC-FET 单囊胚移植。参与者以 1:1 的比例随机分为刺激周期后第一个月经周期行 FET（即刻 FET）或刺激周期后第二个或以后的周期行 FET（延迟 FET）。该研究设计为非劣效性试验，主要分析将根据意向治疗和方案进行。

伦理和传播

丹麦首都大区科学伦理委员会（编号：H-19086300）已批准该研究的伦理许可。数据将根据丹麦个人数据保护法和一般数据保护条例进行处理。参与者将签署书面同意书，同意参与研究和将血样储存在生物库中用于未来的研究。该研究将由经过良好临床实践（GCP）培训的研究护士进行监测，该护士与研究无其他关系。本研究的结果将通过在国际同行评议的科学期刊上发表来进行传播。