Clara Colombo, Amalie Somuncu Johansen, Marte Saupstad, Sara Johanna Bergenheim, Tine Vrist Dam, Nathalie Friis Wang, Birgitte Oxlund-Mariegaard, Ellen Løkkegaard, Merete Husth, Mette Petri Lauritsen, Julie Lyng Forman, Nina La Cour Freiesleben, Bugge Nøhr, Kristine Løssl, Anja Pinborg
{"title":"在刺激或程序化冷冻胚胎移植周期中立即与推迟囊胚移植——一项非盲随机临床试验方案","authors":"Clara Colombo, Amalie Somuncu Johansen, Marte Saupstad, Sara Johanna Bergenheim, Tine Vrist Dam, Nathalie Friis Wang, Birgitte Oxlund-Mariegaard, Ellen Løkkegaard, Merete Husth, Mette Petri Lauritsen, Julie Lyng Forman, Nina La Cour Freiesleben, Bugge Nøhr, Kristine Løssl, Anja Pinborg","doi":"10.61409/A03250214","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>It is standard clinical practice to postpone frozen embryo transfer (FET) for at least one menstrual cycle after a failed fresh embryo transfer or a freeze-all cycle. Delaying FET has been hypothesised to minimise the negative effect of controlled ovarian stimulation. However, this practice may be associated with increased psychological distress and delayed time to pregnancy. In this clinical study, we aim to investigate whether immediate SC- or PC-FET is non-inferior to postponed SC- and PC-FET in terms of live birth rate (LBR).</p><p><strong>Methods: </strong>The study is designed as a multicentre, randomised controlled, non-blinded, non-inferiority trial. A total of 484 women aged 18-45 years who are set to undergo SC- or PC-FET will be included in the trial. Participants will be randomised 1:1 to FET in the first cycle after a failed fresh transfer or freeze all (FET immediate) or to FET in a subsequent cycle (FET postponed). The main outcome will be LBR.</p><p><strong>Conclusions: </strong>If immediate FET proves to be as efficient and safe as postponed FET, immediate FET offers various advantages, such as a shorter time to pregnancy for couples who did not conceive in the fresh cycle and lower expenses due to a shorter freezing time.</p><p><strong>Funding: </strong>This work was supported by a research grant from Merck Denmark. Merck Denmark was in no way involved in the design of the study and will not be involved in the analysis or interpretation of results.</p><p><strong>Trial registration: </strong></p><p><strong>Clinicaltrials: </strong>gov (NCT06304792).</p>","PeriodicalId":11119,"journal":{"name":"Danish medical journal","volume":"72 8","pages":""},"PeriodicalIF":1.2000,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Immediate versus postponed blastocyst transfer in stimulated or programmed frozen embryo transfer cycles - a protocol for a non-blinded randomised clinical trial.\",\"authors\":\"Clara Colombo, Amalie Somuncu Johansen, Marte Saupstad, Sara Johanna Bergenheim, Tine Vrist Dam, Nathalie Friis Wang, Birgitte Oxlund-Mariegaard, Ellen Løkkegaard, Merete Husth, Mette Petri Lauritsen, Julie Lyng Forman, Nina La Cour Freiesleben, Bugge Nøhr, Kristine Løssl, Anja Pinborg\",\"doi\":\"10.61409/A03250214\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>It is standard clinical practice to postpone frozen embryo transfer (FET) for at least one menstrual cycle after a failed fresh embryo transfer or a freeze-all cycle. Delaying FET has been hypothesised to minimise the negative effect of controlled ovarian stimulation. However, this practice may be associated with increased psychological distress and delayed time to pregnancy. In this clinical study, we aim to investigate whether immediate SC- or PC-FET is non-inferior to postponed SC- and PC-FET in terms of live birth rate (LBR).</p><p><strong>Methods: </strong>The study is designed as a multicentre, randomised controlled, non-blinded, non-inferiority trial. A total of 484 women aged 18-45 years who are set to undergo SC- or PC-FET will be included in the trial. Participants will be randomised 1:1 to FET in the first cycle after a failed fresh transfer or freeze all (FET immediate) or to FET in a subsequent cycle (FET postponed). The main outcome will be LBR.</p><p><strong>Conclusions: </strong>If immediate FET proves to be as efficient and safe as postponed FET, immediate FET offers various advantages, such as a shorter time to pregnancy for couples who did not conceive in the fresh cycle and lower expenses due to a shorter freezing time.</p><p><strong>Funding: </strong>This work was supported by a research grant from Merck Denmark. Merck Denmark was in no way involved in the design of the study and will not be involved in the analysis or interpretation of results.</p><p><strong>Trial registration: </strong></p><p><strong>Clinicaltrials: </strong>gov (NCT06304792).</p>\",\"PeriodicalId\":11119,\"journal\":{\"name\":\"Danish medical journal\",\"volume\":\"72 8\",\"pages\":\"\"},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2025-07-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Danish medical journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.61409/A03250214\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Danish medical journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.61409/A03250214","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Immediate versus postponed blastocyst transfer in stimulated or programmed frozen embryo transfer cycles - a protocol for a non-blinded randomised clinical trial.
Introduction: It is standard clinical practice to postpone frozen embryo transfer (FET) for at least one menstrual cycle after a failed fresh embryo transfer or a freeze-all cycle. Delaying FET has been hypothesised to minimise the negative effect of controlled ovarian stimulation. However, this practice may be associated with increased psychological distress and delayed time to pregnancy. In this clinical study, we aim to investigate whether immediate SC- or PC-FET is non-inferior to postponed SC- and PC-FET in terms of live birth rate (LBR).
Methods: The study is designed as a multicentre, randomised controlled, non-blinded, non-inferiority trial. A total of 484 women aged 18-45 years who are set to undergo SC- or PC-FET will be included in the trial. Participants will be randomised 1:1 to FET in the first cycle after a failed fresh transfer or freeze all (FET immediate) or to FET in a subsequent cycle (FET postponed). The main outcome will be LBR.
Conclusions: If immediate FET proves to be as efficient and safe as postponed FET, immediate FET offers various advantages, such as a shorter time to pregnancy for couples who did not conceive in the fresh cycle and lower expenses due to a shorter freezing time.
Funding: This work was supported by a research grant from Merck Denmark. Merck Denmark was in no way involved in the design of the study and will not be involved in the analysis or interpretation of results.
期刊介绍：
The Danish Medical Journal (DMJ) is a general medical journal. The journal publish original research in English – conducted in or in relation to the Danish health-care system. When writing for the Danish Medical Journal please remember target audience which is the general reader. This means that the research area should be relevant to many readers and the paper should be presented in a way that most readers will understand the content.
DMJ will publish the following articles:
• Original articles
• Protocol articles from large randomized clinical trials
• Systematic reviews and meta-analyses
• PhD theses from Danish faculties of health sciences
• DMSc theses from Danish faculties of health sciences.
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