一项随机对照临床试验研究低分子肝素改善多囊卵巢综合征患者行体外受精妊娠结局：研究方案。
A randomized, controlled clinical study of low-molecular-weight heparin improving pregnancy outcomes in PCOS women undergoing IVF: study protocol.
机构信息
Department of General Surgery, Comprehensive Breast Health Center, Ruijing Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200030, China.
出版信息
Trials. 2024 Jan 2;25(1):16. doi: 10.1186/s13063-023-07877-x.
BACKGROUND
Polycystic ovary syndrome (PCOS), an incidence of 10-15% in women of reproductive age, shows sex hormone disorders, luteal insufficiency, and the tendency of placental villus space thrombus. The incidence of early pregnancy loss in women with PCOS is three to eight times higher than that in non-PCOS women. PCOS women were reported in a pre-thrombotic state, which was manifested by accelerated thrombin production, increased PAI-1 activity, and fibrinogen. Other research also found an over-activated state of women with PCOS in immune system. Therefore, changing the prethrombotic state of PCOS through anticoagulation may be a new way to improve the adverse pregnancy outcome of PCOS. Low-molecular-weight heparin (LMWH) is the most common used anticoagulant drug in pregnancy, and it also was proposed for the prevention of recurrent abortion, although the application of LMWH in PCOS population during early pregnancy has not been reported. The objective of this study is to investigate the effect of LMWH on pregnancy outcomes after invitro fertilization-frozen embryo transfer (IVF-FET) in patients with polycystic ovary syndrome.
METHODS
A total of 356 PCOS women aged between 20 and 38 years which prepared for IVF followed with FET will be enrolled in the study. The patients, from four different hospitals stratified by age and body mass index (BMI), will be randomly divided into the study group who will be treated with LMWH started on the day of progesterone transformation (hormone therapy) during FET cycle and the control group without additional medicine. Serum or urine hCG test will be given 14 days after embryo transfer to confirm biochemical pregnancy. If pregnancy is positive, LMWH+ hormone therapy/hormone therapy will be continued for another 2 weeks. Transvaginal ultrasonography will be performed 14 days later to confirm intrauterine pregnancy. The primary outcome is the ongoing pregnancy, which is defined as intrauterine live fetus with ultrasound after 12 weeks of gestation.
DISCUSSION
This is the first study protocol to investigate the efficacy of LMWH as an adjuvant drug for IVF-FET outcomes in PCOS women, by comparing differences in ongoing pregnancy rate, clinical pregnancy rate, live birth rate, and early pregnancy loss rate between LMWH group and the control group.
TRIAL REGISTRATION
ClinicalTrials.gov ChiCTR2000036527. Registered on August 24, 2020.
背景
多囊卵巢综合征（PCOS）在育龄妇女中的发病率为 10-15%，表现为性激素紊乱、黄体功能不全和胎盘绒毛空间血栓形成倾向。PCOS 妇女的早期妊娠丢失发生率是非 PCOS 妇女的三到八倍。有报道称 PCOS 妇女处于血栓前状态，表现为凝血酶生成加速、PAI-1 活性增加和纤维蛋白原增加。其他研究还发现 PCOS 妇女的免疫系统处于过度激活状态。因此，通过抗凝来改变 PCOS 的血栓前状态可能是改善 PCOS 不良妊娠结局的一种新方法。低分子量肝素（LMWH）是妊娠中最常用的抗凝药物，也被提议用于预防复发性流产，尽管 LMWH 在早孕期间 PCOS 人群中的应用尚未报道。本研究旨在探讨 LMWH 对多囊卵巢综合征患者体外受精-冻融胚胎移植（IVF-FET）后妊娠结局的影响。
方法
本研究共纳入 356 名年龄在 20-38 岁之间准备接受 IVF 后 FET 的 PCOS 妇女。将患者按年龄和体重指数（BMI）分层，来自四家不同的医院，然后随机分为研究组和对照组。研究组在 FET 周期中孕激素转化（激素治疗）当天开始接受 LMWH 治疗，对照组不给予额外药物。胚胎移植后 14 天进行血清或尿 hCG 检测以确认生化妊娠。如果妊娠阳性，LMWH+激素治疗/激素治疗将再继续 2 周。14 天后经阴道超声检查以确认宫内妊娠。主要结局是持续妊娠，定义为 12 周后超声可见宫内活胎。
讨论
这是第一项研究方案，旨在通过比较 LMWH 组和对照组之间的持续妊娠率、临床妊娠率、活产率和早期妊娠丢失率，来研究 LMWH 作为辅助药物对 PCOS 妇女 IVF-FET 结局的疗效。
试验注册
ClinicalTrials.gov ChiCTR2000036527. 注册于 2020 年 8 月 24 日。
Zotero 插件