将优质囊胚玻璃化保存 5 年以上可降低植入率和活产率。

IF 6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY
Shaoquan Zhan, Chenxing Lin, Qiwang Lin, Jiayu Gan, Chunyan Wang, Yang Luo, Jianqiao Liu, Hongzi Du, Hanyan Liu
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引用次数: 0

摘要

研究问题:胚胎玻璃化冷冻保存超过 5 年是否会影响冷冻胚胎移植(FET)后的妊娠结局?对优质囊胚进行玻璃化冷冻保存超过 5 年与植入率(IR)和活产率(LBR)的降低有关:以往的研究主要针对冷冻时间相对较短(少于 5 年)的胚胎,但延长冷冻时间对妊娠结局的影响仍是一个有争议的问题。有关胚胎保存 5 年或更长时间的有效性和安全性的数据相对较少:这项回顾性研究涉及中国一家生殖中心2016年1月1日至2022年12月31日期间36 665个符合条件的玻璃化解冻胚胎移植周期:根据胚胎储存时间将患者分为三组:第一组包括 31 565 个周期,储存时间为 0-2 年;第二组包括 4458 个周期,储存时间为 2-5 年;第三组包括 642 个周期,储存时间超过 5 年。主要结果指标为IR和LBR。次要结局变量包括生化妊娠率、多胎妊娠率、异位妊娠率、流产率以及新生儿结局。生殖结果作为二元变量进行分析。在校正了混杂因素后,我们使用多变量逻辑回归分析来探讨保存时间对妊娠结局的影响。此外,我们还评估了新生儿结局,如胎龄过大(LGA)和胎龄过小(SGA):三组(0-2 岁、2-5 岁和大于 5 岁)的 IR 分别为 37.37%、39.03% 和 35.78%(P = 0.017),三组的 LBR 分别为 37.29%、39.09% 和 34.91%(P = 0.028)。在调整了潜在的混杂因素后,与 0-2 年保存组相比,延长胚胎玻璃化保存时间(2-5 年或 >5 年)不会影响生化妊娠率、多胎妊娠率、异位妊娠率和流产率等次要结局(P > 0.05)。但胚胎冷冻保存超过 5 年会降低 IR(调整后的几率比 (aOR) 0.82,95% CI 0.69-0.97,P = 0.020)和 LBR(aOR 0.76,95% CI 0.64-0.91,P = 0.002)。多变量分层分析还显示,延长囊胚冷冻保存时间(>5 年)可降低 IR(aOR 0.78,95% CI 0.62-0.98,P = 0.033)和 LBR(aOR 0.68,95% CI 0.53-0.87,P = 0.002)。但是,没有观察到对裂殖胚胎的影响(P > 0.05)。我们进一步根据移植冷冻囊胚的数量和质量进行了分层分析,结果显示,在储存时间大于 5 年的组别中,移植优质囊胚后的 FET 结果会受到负面影响。然而,非优质囊胚的储存时间与妊娠结局无明显关联。在新生儿(单胎)结局方面,胚胎玻璃化保存时间对早产率、胎儿出生体重和新生儿性别比没有影响。然而,随着保存时间的延长,SGA 率(5.60%、4.10% 和 1.18%)下降,而 LGA 率(5.22%、6.75% 和 9.47%)上升(P 局限性,需谨慎的原因:这是一项回顾性研究,使用的数据来自一个生育中心,尽管数据已经过调整,但我们的研究结果仍需进一步研究验证:研究结果的广泛意义:随着中国二胎政策的全面实施,未来可能会有更多患者的胚胎被冷冻更长时间。患者应注意,当冷冻时间超过 5 年时,囊胚的 IR 和 LBR 会受到负面影响。因此,夫妇可考虑缩短 FET 治疗的时间:本研究得到了国家自然科学基金(编号:82101672)、广州市科技计划项目(编号:2024A03J0180)、广州市卫计委西医综合指导项目(编号:20231A011096)和广州市医学重点学科(2021-2023)的资助。所有作者均无任何利益冲突需要声明:不详。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Vitrification preservation of good-quality blastocysts for more than 5 years reduces implantation and live birth rates.

Study question: Does vitrification cryopreservation of embryos for more than 5 years affect the pregnancy outcomes after frozen embryo transfer (FET)?

Summary answer: Vitrification cryopreservation of good-quality blastocysts for more than 5 years is associated with a decrease in the implantation rate (IR) and live birth rate (LBR).

What is known already: Previous studies have predominantly focused on embryos cryopreserved for relatively short durations (less than 5 years), yet the impact of extended cryopreservation duration on pregnancy outcomes remains a controversial issue. There is a relative scarcity of data regarding the efficacy and safety of storing embryos for 5 years or longer.

Study design, size, duration: This retrospective study involved 36 665 eligible vitrified-thawed embryo transfer cycles from 1 January 2016 to 31 December 2022, at a single fertility center in China.

Participants/materials, setting, methods: Patients were divided into three groups according to embryo storage time: Group 1 consisted of 31 565 cycles, with storage time of 0-2 years; Group 2 consisted of 4458 cycles, with a storage time of 2-5 years; and Group 3 included 642 cycles, with storage time exceeding 5 years. The main outcome measures were IR and LBR. Secondary outcome variables included rates of biochemical pregnancy, multiple pregnancy, ectopic pregnancy, and miscarriage, as well as neonatal outcomes. Reproductive outcomes were analyzed as binary variables. Multivariate logistic regression analysis was used to explore the effect of preservation time on pregnancy outcomes after correcting for confounding factors. In addition, we also assessed neonatal outcomes, such as large for gestational age (LGA) and small for gestational age (SGA).

Main results and the role of chance: IRs in the three groups (0-2, 2-5, and >5 years) were 37.37%, 39.03%, and 35.78%, respectively (P = 0.017), and LBRs in the three groups were 37.29%, 39.09%, and 34.91%, respectively (P = 0.028). After adjustment for potential confounding factors, compared with the 0-2 years storage group, prolonged embryo vitrification preservation time (2-5 years or >5 years) did not affect secondary outcomes such as rates of biochemical pregnancy, multiple pregnancy, ectopic pregnancy, and miscarriage (P > 0.05). But cryopreservation of embryos for more than 5 years reduced the IR (adjusted odds ratio (aOR) 0.82, 95% CI 0.69-0.97, P = 0.020) and LBR (aOR 0.76, 95% CI 0.64-0.91, P = 0.002). Multivariate stratified analysis also showed that prolonging the cryopreservation time of blastocysts (>5 years) reduced the IR (aOR 0.78, 95% CI 0.62-0.98, P = 0.033) and LBR (aOR 0.68, 95% CI 0.53-0.87, P = 0.002). However, no effect on cleavage embryos was observed (P > 0.05). We further conducted stratified analyses based on the number and quality of frozen blastocysts transferred, and the results showed that the FET results after transfers of good-quality blastocysts in the >5 years storage group were negatively affected. However, the storage time of non-good-quality blastocysts was not significantly associated with pregnancy outcomes. Regarding the neonatal outcomes (of singletons), embryo vitrification preservation time had no effect on preterm birth rates, fetal birth weight, or neonatal sex ratios. However, as the storage time increased, rates of SGA (5.60%, 4.10%, and 1.18%) decreased, while rates of LGA (5.22%, 6.75%, and 9.47%) increased (P < 0.05). After adjusting for confounding factors, the increase in LGA and the decrease in SGA were significantly correlated with the duration of storage time.

Limitations, reasons for caution: This was a retrospective study using data from a single fertility center, even though the data had been adjusted, our findings still need to be validated in further studies.

Wider implications of the findings: With the full implementation of the two-child policy in China, there may be more patients whose embryos have been frozen for a longer time in the future. Patients should be aware that the IR and LBR of blastocysts are negatively affected when the cryopreservation time is longer than 5 years. Couples may therefore consider shortening the time until FET treatment.

Study funding/competing interest(s): This study was supported by the National Nature Science Foundation of China (No. 82101672), Science and Technology Projects in Guangzhou (No. 2024A03J0180), General Guidance Program for Western Medicine of Guangzhou Municipal Health Commission (No. 20231A011096), and the Medical Key Discipline of Guangzhou (2021-2023). None of the authors have any conflicts of interest to declare.

Trial registration number: N/A.

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来源期刊
Human reproduction
Human reproduction 医学-妇产科学
CiteScore
10.90
自引率
6.60%
发文量
1369
审稿时长
1 months
期刊介绍: Human Reproduction features full-length, peer-reviewed papers reporting original research, concise clinical case reports, as well as opinions and debates on topical issues. Papers published cover the clinical science and medical aspects of reproductive physiology, pathology and endocrinology; including andrology, gonad function, gametogenesis, fertilization, embryo development, implantation, early pregnancy, genetics, genetic diagnosis, oncology, infectious disease, surgery, contraception, infertility treatment, psychology, ethics and social issues.
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