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超短 GnRH 拮抗剂联合生长激素在 IVF/ICSI 中对卵巢低反应患者的疗效:一项随机对照试验。

Efficacy of growth hormone supplementation with ultrashort GnRH antagonist in IVF/ICSI for poor responders; randomized controlled trial.

机构信息

Department of Gynecology and Obstetrics, Faculty of Medicine, Al-Azhar University, Egypt.

Department of Embryology, International Islamic Center for Population Studies & Research, Al Azhar University, Egypt.

出版信息

Taiwan J Obstet Gynecol. 2021 Jan;60(1):51-55. doi: 10.1016/j.tjog.2020.10.003.

Abstract

OBJECTIVES

To compare the ICSI-ET outcomes in poor responders who underwent ovarian stimulation by the ultrashort GnRH antagonist protocol with or without adjuvant GH injection.

MATERIAL AND METHODS

This randomized controlled study was conducted at Al-Azhar University from December-2018 to June-2019 upon 156 participants. All patients received the same preparations. After randomization, in the study group, women have received GH 4 IU/day subcutaneous injection from the second day of the cycle stopped one day before ovum pickup. While in the control group, women have received subcutaneous saline in the same dosing as in the study group. After intervention, all procedures were the same in both groups. The main outcome measure was the clinical pregnancy rate. Statistical analysis was based on the intention-to-treat population.

RESULTS

Both groups were comparable with regard their baseline characteristics (p-values > 0.05). Ovulation characteristics were comparable (p-values > 0.05). The level of E2 is significantly (p-value = 0.003) higher in the GH group. The oocyte retrieved number was significantly (p-value < 0.001) higher in the GH group 4.94 ± 1.77 than in the control group 3.74 ± 1.82. The mean number of MII oocytes was significantly (p-value < 0.001) higher in the GH group 3.3 ± 1.36 than in the control group 2.29 ± 1.24. Fertilization characteristics, implantation rate, pregnancy rate were comparable (p-values > 0.05).

CONCLUSION

Despite the fact that this study showed no significant increase in the clinical and chemical pregnancy rates by the addition of GH to the ultrashort antagonist protocol in poor responders, the number of retrieved oocytes was significantly higher in the GH group.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03759301.

摘要

目的

比较接受超短 GnRH 拮抗剂方案卵巢刺激的反应不良者中,联合或不联合辅助生长激素(GH)注射的 ICSI-ET 结局。

材料和方法

这项随机对照研究于 2018 年 12 月至 2019 年 6 月在艾资哈尔大学进行,共有 156 名参与者。所有患者均接受相同的准备。随机分组后,研究组的女性从周期停止的第二天开始每天皮下注射 4IU 的 GH,在取卵前一天停止注射。而在对照组,女性在同一剂量下接受皮下生理盐水注射。干预后,两组的所有程序均相同。主要观察指标是临床妊娠率。统计分析基于意向治疗人群。

结果

两组患者的基线特征(p 值>0.05)具有可比性。排卵特征也具有可比性(p 值>0.05)。GH 组的 E2 水平显著升高(p 值=0.003)。GH 组的获卵数明显高于对照组(p 值<0.001),分别为 4.94±1.77 个和 3.74±1.82 个。GH 组的成熟 MII 卵母细胞数明显高于对照组(p 值<0.001),分别为 3.3±1.36 个和 2.29±1.24 个。受精特征、着床率和妊娠率无显著差异(p 值>0.05)。

结论

尽管本研究表明,在超短拮抗剂方案中添加 GH 并不能显著提高反应不良者的临床和生化妊娠率,但 GH 组的获卵数明显增加。

临床试验注册

ClinicalTrials.gov 标识符:NCT03759301。

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