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BlastGen 研究:补充粒细胞-巨噬细胞集落刺激因子的囊胚培养基的随机对照试验。

The BlastGen study: a randomized controlled trial of blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor.

机构信息

Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.

Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.

出版信息

Reprod Biomed Online. 2020 May;40(5):645-652. doi: 10.1016/j.rbmo.2020.01.011. Epub 2020 Jan 23.

DOI:10.1016/j.rbmo.2020.01.011
PMID:32220517
Abstract

RESEARCH QUESTION

Does Embryogen®/BlastGen™ culture medium improve live birth rates compared with standard culture medium for women undergoing IVF and intracytoplasmic sperm injection (ICSI) with poor prognosis.

DESIGN

Randomized clinical trial. A total of 100 couples undergoing IVF/ICSI were randomly allocated to having their inseminated oocytes incubated in either Embryogen®/BlastGen™ sequential culture media or standard Cleavage/Blastocyst sequential culture media for 5 days (ClinicalTrials.gov Identifier: NCT02305420).

RESULTS

No statistically significant difference in live birth rate was found between the control group and the Embryogen®/BlastGen™ group (17 [34%] versus 11 [22%], respectively) (OR 0.55; 95% CI 0.22 to 1.32; P = 0.18). After adjustment for maternal age, body mass index and fertilization procedure, the blastulation rate reduced (40.6 ± 26.5 versus 24.6 ± 26.7; RR 0.70, CI 0.52 to 0.95; P < 0.05), and grade of the embryo transferred (OR 0.35, CI 0.16 to 0.77; P < 0.01) when Embryogen®/BlastGen™ medium was used.

CONCLUSION

A significant reduction in day-5 embryo outcome parameters was found using Embryogen®/BlastGen™ compared with standard medium, and insufficient evidence of a difference in pregnancy outcomes. Taking into consideration the small samples size, study limitations and strict inclusion criteria of this single-centre study, further research is needed to determine the efficacy of Embryogen®/BlastGen™ medium in couples undergoing IVF/ICSI.

摘要

研究问题

与标准培养基相比,Embryogen®/BlastGen™培养基于行 IVF 和胞浆内单精子注射(ICSI)且预后不良的女性,是否能提高活产率。

设计

随机临床试验。共 100 对接受 IVF/ICSI 的夫妇被随机分配,将受精的卵母细胞在 Embryogen®/BlastGen™序贯培养物或标准分裂/囊胚序贯培养物中孵育 5 天(ClinicalTrials.gov 标识符:NCT02305420)。

结果

对照组和 Embryogen®/BlastGen™组的活产率无统计学差异(分别为 17 [34%]和 11 [22%])(OR 0.55;95%CI 0.22 至 1.32;P=0.18)。调整母亲年龄、体重指数和受精程序后,囊胚形成率降低(40.6±26.5 与 24.6±26.7;RR 0.70,95%CI 0.52 至 0.95;P<0.05),使用 Embryogen®/BlastGen™ 培养基时转移胚胎的等级(OR 0.35,95%CI 0.16 至 0.77;P<0.01)。

结论

与标准培养基相比,Embryogen®/BlastGen™培养基使用时第 5 天胚胎结局参数显著降低,但妊娠结局差异证据不足。考虑到本单中心研究的样本量小、研究局限性和严格的纳入标准,需要进一步研究以确定 Embryogen®/BlastGen™培养基在接受 IVF/ICSI 的夫妇中的疗效。

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