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.
Taiwan J Obstet Gynecol. 2021 Jan;60(1):51-55. doi: 10.1016/j.tjog.2020.10.003.
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.
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.
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).
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.
ClinicalTrials.gov Identifier: NCT03759301.
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。
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。
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）。
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。
ClinicalTrials.gov 标识符：NCT03759301。
