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胚胎移植前宫腔内注射 HCG:一项平行、双盲、随机试验。

Intrauterine injection of HCG before embryo transfer: a parallel, double-blind randomized trial.

机构信息

Department of Obstetrics and Gynecology, Women's Health Hospital, Faculty of Medicine, Assiut University, Assiut 71515, Egypt; Department of Obstetrics and Gynecology, Monash University, Monash Medical Center, 246 Clayton Road, Clayton VIC 3168, Australia.

Department of Obstetrics and Gynecology, Women's Health Hospital, Faculty of Medicine, Assiut University, Assiut 71515, Egypt.

出版信息

Reprod Biomed Online. 2021 Oct;43(4):663-669. doi: 10.1016/j.rbmo.2021.06.011. Epub 2021 Jun 20.

DOI:10.1016/j.rbmo.2021.06.011
PMID:34412973
Abstract

RESEARCH QUESTION

Does intrauterine administration of HCG before embryo transfer improve live birth rate during IVF cycles?

DESIGN

A parallel, randomized controlled trial conducted between July 2018 and February 2020. Infertile women (n = 181) scheduled for fresh or vitrified-warmed embryo transfer after IVF carried out for any indication were randomized in a 1:1 ratio to receive either HCG (500 IU in 0.1 ml of tissue culture media) or culture media (0.1 ml of tissue culture media) via intrauterine injection 4 min before embryo transfer. In both groups, an intrauterine insemination catheter was used for administering the medication. Primary outcome was live birth, with ongoing pregnancy and clinical pregnancy as secondary outcomes. Analysis was based on intention-to-treat principle.

RESULTS

Baseline and cycle characteristics were comparable between the two groups. In the control group, one woman with a confirmed clinical pregnancy was lost to follow-up. Live birth rates were 24% (22/90) in the HCG group versus 19% (17/90) in the control group (RR 1.29, 95% CI 0.74 to 2.27). Clinical pregnancy and ongoing pregnancy rates were 34% versus 26% (RR 1.31, 95% CI 0.84 to 2.04) and 24% versus 19% (RR 1.29, 95% CI 0.74 to 2.27) in the HCG and the control groups, respectively.

CONCLUSION

Intrauterine injection of HCG before embryo transfer did not improve live birth rates in women undergoing IVF. As the study was designed to detect a 20% difference between groups, a smaller, clinically important difference could not be ruled out. Treatment outcomes were lower than expected in the control group.

摘要

研究问题

胚胎移植前宫腔内注射人绒毛膜促性腺激素是否能提高体外受精周期的活产率?

设计

这是一项在 2018 年 7 月至 2020 年 2 月期间进行的平行、随机对照试验。将因任何原因接受体外受精后进行新鲜或玻璃化冷冻胚胎移植的不孕妇女(n=181)按 1:1 的比例随机分为两组,一组在胚胎移植前 4 分钟宫腔内注射 500IU 的人绒毛膜促性腺激素(HCG)(0.1ml 组织培养液),另一组注射 0.1ml 组织培养液。两组均采用宫腔内授精导管给药。主要结局为活产,次要结局为持续妊娠和临床妊娠。分析基于意向治疗原则。

结果

两组的基线和周期特征无差异。对照组有 1 例临床妊娠患者失访。HCG 组的活产率为 24%(22/90),对照组为 19%(17/90)(RR 1.29,95%CI 0.74-2.27)。HCG 组和对照组的临床妊娠率和持续妊娠率分别为 34%和 26%(RR 1.31,95%CI 0.84-2.04)和 24%和 19%(RR 1.29,95%CI 0.74-2.27)。

结论

胚胎移植前宫腔内注射 HCG 不能提高体外受精患者的活产率。由于该研究旨在检测两组之间 20%的差异,因此不能排除更小的、有临床意义的差异。对照组的治疗结局低于预期。

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