阿托西班治疗既往单胚胎种植失败行冻融囊胚移植妇女的有效性：一项随机对照试验的研究方案。
Effectiveness of atosiban in women with previous single implantation failure undergoing frozen-thawed blastocyst transfer: study protocol for a randomised controlled trial.
机构信息
The Assisted Reproduction Center, Northwest Women's and Children's Hospital, Xi'an, China.
Guangzhou Kapok Medical Group, Guangzhou, China.
出版信息
BMJ Open. 2023 Oct 16;13(10):e076390. doi: 10.1136/bmjopen-2023-076390.
BACKGROUND
Uterine contractions may interfere with embryo implantation in assisted reproductive technology. To reduce these contractions and improve success rates, the oxytocin antagonist atosiban has been suggested for administration during embryo transfer. The aim of this study is to evaluate the effectiveness of atosiban in increasing live birth rates among women who have previously experienced a single implantation failure and are scheduled for single blastocyst transfer.
METHODS AND ANALYSIS
We conduct a single-centre randomised controlled study comparing atosiban and placebo in women undergoing a single blastocyst transfer with a previous failed blastocyst transfer. Women with endocrine or systemic illnesses, recurrent miscarriages, uterine malformations or fibroids, untreated hydrosalpinx, endometriosis (stage III or IV) or uterine fibroids, as well as women undergoing preimplantation genetic testing, are ineligible. The primary outcome is live birth resulting from the frozen-thawed embryo transfer. Secondary outcomes include biochemical/clinical pregnancy, miscarriage, ectopic pregnancy, multiple pregnancies as well as maternal and perinatal outcomes. We plan to recruit 1100 women (550 women per group). This will allow us to demonstrate or refute an increase in live birth rate from 40% to 50%. Data analysis will follow the intention-to-treat principle. We will measure patterns of uterine peristalsis which will allow subgroup analysis for women with or without uterine peristalsis.
ETHICS AND DISSEMINATION
This study has been approved by the Institutional Review Board of Northwest Women's and Children's Hospital (No. SZ2019001). Written informed consent will be obtained from each participant before randomisation. The results of the trial will be presented at scientific meetings and reported in publications.
TRIAL REGISTRATION NUMBER
ChiCTR1900022333.
背景
子宫收缩可能会干扰辅助生殖技术中的胚胎着床。为了减少这些收缩并提高成功率，有人建议在胚胎移植期间使用催产素拮抗剂阿托西班。本研究旨在评估阿托西班对既往单枚胚胎移植失败且计划行单囊胚移植的女性增加活产率的有效性。
方法和分析
我们进行了一项单中心随机对照研究，比较了阿托西班和安慰剂在既往单枚胚胎移植失败且计划行单囊胚移植的女性中的作用。患有内分泌或系统性疾病、复发性流产、子宫畸形或肌瘤、未治疗的输卵管积水、子宫内膜异位症（III 或 IV 期）或子宫肌瘤、以及行胚胎植入前遗传学检测的女性不符合入组条件。主要结局是冻融胚胎移植后的活产。次要结局包括生化/临床妊娠、流产、异位妊娠、多胎妊娠以及母婴围产期结局。我们计划招募 1100 名女性（每组 550 名女性）。这将使我们能够证明或反驳活产率从 40%增加到 50%。数据分析将遵循意向治疗原则。我们将测量子宫蠕动模式，这将允许对有或没有子宫蠕动的女性进行亚组分析。
伦理和传播
本研究已获得西北妇女儿童医院机构审查委员会的批准（编号：SZ2019001）。在随机分组前，将获得每位参与者的书面知情同意。试验结果将在科学会议上展示，并在出版物中报告。
注册号
ChiCTR1900022333。
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