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常规浓度与增加浓度蔗糖在人类胚胎冷冻和解冻溶液中的实用性随机对照试验。

A pragmatic RCT of conventional versus increased concentration sucrose in freezing and thawing solutions for human embryos.

机构信息

Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.

出版信息

Hum Reprod. 2011 Aug;26(8):1987-96. doi: 10.1093/humrep/der147. Epub 2011 May 16.

DOI:10.1093/humrep/der147
PMID:21586432
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3137387/
Abstract

BACKGROUND

Intact frozen-thawed embryos have a greater potential than damaged embryos to establish successful pregnancies. This study aimed to determine whether elevated concentrations of sucrose during freezing would increase the proportion of patients with ≥ 50% of embryos intact after thawing (primary outcome), and improve clinical outcome.

METHODS

In a two arm, parallel group, pragmatic trial, IVF/ICSI couples were randomized prospectively to have their supernumerary embryos frozen in a medium containing 0.1 M sucrose (control; n = 99) or 0.3 M sucrose (intervention; n = 102).

RESULTS

More control (74/99) than intervention (63/102) couples had at least one embryo thawed (P = 0.07). Significantly more (P = 0.005) intervention (53/63) than control (45/74) couples had ≥ 50% of embryos intact. Freezing in a medium containing 0.3 M sucrose increased by 3.4-fold [95% confidence interval (CI) (1.45, 7.82)] the likelihood of a couple having ≥ 50% of their embryos intact. In the fresh cycle, live birth rate per transfer was similar in the control (35/95) and intervention (36/93) groups (P = 0.91). More control (19/63) than intervention (9/59) couples had a live birth after frozen embryo transfer (P = 0.08). When fresh and frozen cycles were combined, fewer intervention (n = 102) than control (n = 99) couples had at least one live birth (42 versus 53%). The difference in cumulative live birth rate was not significant [hazard ratio = 0.75, 95% CI (0.49, 1.13); P = 0.17].

CONCLUSIONS

Increasing the concentration of sucrose in the freezing medium improves embryo survival, but this is not reflected by increased cumulative birth rates.

CLINICAL TRIALS REGISTRATION NUMBER

ISRCTN93314892.

摘要

背景

完整的冷冻解冻胚胎比受损胚胎更有潜力建立成功的妊娠。本研究旨在确定在冷冻过程中升高蔗糖浓度是否会增加解冻后胚胎完整率≥50%的患者比例(主要结局),并改善临床结局。

方法

在一项两臂、平行组、实用试验中,将 IVF/ICSI 夫妇前瞻性随机分为两组,将其多余胚胎在含有 0.1 M 蔗糖的培养基中(对照组;n = 99)或 0.3 M 蔗糖的培养基中(干预组;n = 102)冷冻。

结果

与干预组(63/102)相比,更多的对照组(74/99)夫妇有至少一个胚胎解冻(P = 0.07)。干预组(53/63)胚胎完整率≥50%的比例显著高于对照组(45/74)(P = 0.005)。在含有 0.3 M 蔗糖的培养基中冷冻将夫妇胚胎完整率≥50%的可能性增加了 3.4 倍[95%置信区间(CI)(1.45,7.82)]。在新鲜周期中,对照组(35/95)和干预组(36/93)的活产率相似(P = 0.91)。在冷冻胚胎移植后,对照组(19/63)比干预组(9/59)有更多的夫妇活产(P = 0.08)。当新鲜和冷冻周期结合时,干预组(n = 102)比对照组(n = 99)有更少的夫妇至少有一次活产(42 比 53%)。累积活产率的差异无统计学意义[风险比=0.75,95%CI(0.49,1.13);P = 0.17]。

结论

提高冷冻液中蔗糖的浓度可以提高胚胎存活率,但这并没有反映在增加的累积出生率上。

临床试验注册号

ISRCTN93314892。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bd8d/3137387/4ad8eab8fe93/der14702.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bd8d/3137387/3117025bdd75/der14701.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bd8d/3137387/4ad8eab8fe93/der14702.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bd8d/3137387/3117025bdd75/der14701.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bd8d/3137387/4ad8eab8fe93/der14702.jpg

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