Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam; IVFMD and HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.
IVFMD and HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.
Lancet. 2024 Jul 20;404(10449):266-275. doi: 10.1016/S0140-6736(24)00756-6. Epub 2024 Jun 26.
Use of frozen embryo transfer (FET) in in-vitro fertilisation (IVF) has increased. However, the best endometrial preparation protocol for FET cycles is unclear. We compared natural and modified natural cycle strategies with an artificial cycle strategy for endometrial preparation before FET.
In this randomised, open-label study, we recruited ovulatory women aged 18-45 years at a hospital in Ho Chi Minh City, Viet Nam, who were randomly allocated (1:1:1) to natural, modified natural, or artificial cycle endometrial preparation using a computer-generated random list and block randomisation. The trial was not masked due to the nature of the study interventions. In natural cycles, no oestrogen, progesterone, or human chorionic gonadotropin (hCG) was used. In modified natural cycles, hCG was used to trigger ovulation. In artificial cycles, oral oestradiol valerate (8 mg/day from day 2-4 of menstruation) and vaginal progesterone (800 mg/day starting when endometrial thickness was ≥7 mm) were used. Embryos were vitrified, and then one or two day-3 embryos or one day-5 embryo were warmed and transferred under ultrasound guidance. If the first FET cycle was cancelled, subsequent cycles were performed with artificial endometrial preparation. The primary endpoint was livebirth after one FET. This trial is registered at ClinicalTrials.gov, NCT04804020.
Between March 22, 2021, and March 14, 2023, 4779 women were screened and 1428 were randomly assigned (476 to each group). 99 first FET cycles were cancelled in each of the natural and modified cycle groups, versus none in the artificial cycle group. The livebirth rate after one FET was 174 (37%) of 476 in the natural cycle strategy group, 159 (33%) of 476 in the modified natural cycle strategy group, and 162 (34%) of 476 in the artificial cycle strategy group (relative risk 1·07 [95% CI 0·87-1·33] for natural vs artificial cycle strategy, and 0·98 [0·79-1·22] for modified natural vs artificial cycle strategy). Maternal and neonatal outcomes did not differ significantly between groups, as the power to detect small differences was low.
Although the livebirth rate was similar after natural, modified natural, and artificial cycle endometrial preparation strategies in ovulatory women undergoing FET IVF, no definitive conclusions can be made regarding the comparative safety of the three approaches.
None.
体外受精（IVF）中使用冷冻胚胎移植（FET）的情况有所增加。然而，FET 周期中最佳的子宫内膜准备方案仍不清楚。我们比较了自然和改良自然周期策略与人工周期策略在 FET 前的子宫内膜准备情况。
这是一项在越南胡志明市的一家医院进行的随机、开放标签研究，招募了年龄在 18-45 岁之间、排卵正常的女性，她们按照 1:1:1 的比例随机分配到自然、改良自然或人工周期子宫内膜准备组，使用计算机生成的随机列表和区组随机化。由于研究干预措施的性质，试验未设盲。在自然周期中，不使用雌激素、孕激素或人绒毛膜促性腺激素（hCG）。在改良自然周期中，使用 hCG 触发排卵。在人工周期中，口服戊酸雌二醇（8mg/天，从月经第 2-4 天开始）和阴道用黄体酮（当子宫内膜厚度≥7mm 时开始每天 800mg）。胚胎被冷冻，然后在超声引导下解冻一个或两个第 3 天的胚胎或一个第 5 天的胚胎进行移植。如果第一次 FET 周期被取消，随后的周期将采用人工子宫内膜准备。主要终点是一次 FET 后的活产率。该试验在 ClinicalTrials.gov 注册，NCT04804020。
2021 年 3 月 22 日至 2023 年 3 月 14 日，共有 4779 名女性接受了筛查，其中 1428 名被随机分配（每组 476 名）。自然和改良周期组各有 99 个首次 FET 周期被取消，而人工周期组则没有。自然周期组一次 FET 后的活产率为 476 例中的 174 例（37%），改良自然周期组为 476 例中的 159 例（33%），人工周期组为 476 例中的 162 例（相对风险 1.07[95%CI 0.87-1.33]，自然周期组与人工周期组相比，改良自然周期组与人工周期组相比）。各组间母婴结局无显著差异，因为检测微小差异的效能较低。
虽然在接受 FET IVF 的排卵正常女性中，自然、改良自然和人工周期子宫内膜准备策略后的活产率相似，但无法确定这三种方法的相对安全性。
无。
