Jiang Wen-Jing, Sun Zhen-Gao, Song Jing-Yan
The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, China.
Reproductive Center of Integrated Medicine, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.
Front Med (Lausanne). 2022 Nov 15;9:1014946. doi: 10.3389/fmed.2022.1014946. eCollection 2022.
Nowadays, frozen-thawed embryo transfer (FET) has become one of the standard treatments for infertility in the field of assisted reproductive technology (ART). Natural cycle FET (NC-FET) has many advantages, such as simplicity and economics, no effect on patients' menstrual cycles, estrogen and progesterone levels, as well as no interference in endometrial growth and transformation, which is aligned with the natural physiological state of embryo implantation. Nonetheless, there is a controversy regarding the need for luteal phase support (LPS) during NC-FET cycles. The purpose of this study is to assess whether LPS was not inferior to non-LPS in terms of OPR in NC-FET cycles.
This study including 1,010 ovulatory women undergoing fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles with an elective freeze-all strategy followed by NC-FET will be performed at four university-affiliated reproductive centers. Participants will be randomly assigned in a 1:1 ratio to receive LPS treatment or not. This study is designed as an open-label, non-inferiority, randomized controlled trial (RCT), and the primary statistical strategies were intention-to-treat (ITT) and per-protocol (PP) analysis.
There may not have been any significant difference in the chance of a live birth after FET if no progesterone was supplemental during the luteal phase. However, due to the limited number of previous studies, which are mainly retrospective, evidence is still limited. Thus, by conducting this multicenter RCT, we intend to evaluate whether LPS is necessary in NC-FET.
A Reproductive Ethics Committee of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine (SDUTCM) has approved this study. This study will handle the data as required by general data protection regulations. Participants will sign a written informed consent regarding participation in the study and storage of blood samples in a biobank for future research. This study will be monitored by study personnel trained in Good Clinical Practice who are not involved in the study. The results of this study will be disseminated through publication in international peer-reviewed scientific journals.
[https://www.chictr.org.cn/], identifier [ChiCTR2200057498].
如今，冻融胚胎移植（FET）已成为辅助生殖技术（ART）领域治疗不孕症的标准方法之一。自然周期FET（NC-FET）具有诸多优势，如操作简单、经济实惠，对患者月经周期、雌激素和孕激素水平无影响，也不干扰子宫内膜的生长和转化，这与胚胎着床的自然生理状态相符。然而，关于NC-FET周期中黄体期支持（LPS）的必要性存在争议。本研究的目的是评估在NC-FET周期中，LPS在活产率（OPR）方面是否不劣于非LPS。
本研究将在四家大学附属医院的生殖中心进行，纳入1010名接受体外受精（IVF）/卵胞浆内单精子注射（ICSI）周期且采用选择性全冻存策略随后进行NC-FET的排卵女性。参与者将按1:1比例随机分配接受LPS治疗或不接受。本研究设计为开放标签、非劣效性随机对照试验（RCT），主要统计策略为意向性分析（ITT）和符合方案分析（PP）。
如果在黄体期不补充孕激素，FET后活产的几率可能没有显著差异。然而，由于先前研究数量有限，且主要为回顾性研究，证据仍然有限。因此，通过开展这项多中心RCT，我们旨在评估NC-FET中LPS是否必要。
山东中医药大学附属医院生殖伦理委员会已批准本研究。本研究将按照通用数据保护法规的要求处理数据。参与者将签署关于参与研究以及将血样存储在生物样本库以供未来研究的书面知情同意书。本研究将由接受过良好临床实践培训且不参与研究的人员进行监测。本研究结果将通过在国际同行评审科学期刊上发表进行传播。
