Gazzo Irene, Bovis Francesca, Colia Denise, Sozzi Fausta, Costa Mauro, Anserini Paola, Massarotti Claudia
I Gazzo, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
F Bovis, Department of Health Sciences, University of Genoa, Genova, Italy.
Reprod Fertil. 2024 Feb 1;5(1). doi: 10.1530/RAF-23-0045.
In the registrational trials, follitropin delta was compared with a fixed dose of 150 UI of follitropin alpha/beta, finding higher chances to reach a target response of 8-14 oocytes compared to controls. For this reason, follitropin delta is marketed as particularly useful in expected hyper-responder patients. The main outcome of this study is to report if comparable results are reached in a real-life scenario with follitropin alpha/beta personalized doses, based on patients' characteristics. This is a retrospective study performed in two public fertility centres. All first cycles from January 2020 to June 2022 with either follitropin delta (cases) or alpha/beta (controls) in patients with antiMüllerian hormone >2.5 ng/ml were compared by an inverse probability weighting approach based on propensity score. The follitropin total dose was higher in controls (1179.06 ± 344.93 vs. 1668.67 ± 555.22 IU, p<0.001). The target response of 8-14 oocytes was reached by 40.2% of cases and 40.7% of controls (odds ratio (OR) 0.99, 95% confidence interval (CI) 0.65-1.53, p=0.98). Fewer than 8 oocytes were collected in 24.1% of cases and 22% of controls (OR 1.10, 95% CI 0.71-1.69, p=0.67); more than 14 oocytes in 35.7% of cases and 37.3% of controls (OR 0.83, 95% CI 0.54-1.28, p=0.40). Our experience did not find worse results in term of proportion of patients who reached the target response with an algorithm-chosen dose of follitropin delta compared to a personalised starting dose of follitropin alpha/beta, with follitropin delta having the advantage of objectivity. Larger numbers are needed to confirm these results.
在注册试验中，将注射用重组促卵泡素δ与固定剂量150 UI的注射用重组促卵泡素α/β进行比较，结果发现与对照组相比，达到8 - 14个卵母细胞目标反应的几率更高。因此，注射用重组促卵泡素δ作为对预期高反应患者特别有用的药物上市。本研究的主要结果是报告在实际临床中，根据患者特征使用注射用重组促卵泡素α/β的个性化剂量时是否能达到类似结果。这是一项在两个公共生育中心进行的回顾性研究。采用基于倾向评分的逆概率加权法，比较了2020年1月至2022年6月期间抗苗勒管激素>2.5 ng/ml的患者使用注射用重组促卵泡素δ（病例组）或α/β（对照组）的所有首次周期。对照组的促卵泡素总剂量更高（1179.06±344.93 vs. 1668.67±555.22 IU，p<0.001）。40.2%的病例组和40.7%的对照组达到了8 - 14个卵母细胞的目标反应（优势比（OR）0.99，95%置信区间（CI）0.65 - 1.53，p = 0.98）。24.1%的病例组和22%的对照组收集到的卵母细胞少于8个（OR 1.10，95% CI 0.71 - 1.69，p = 0.67）；35.7%的病例组和37.3%的对照组收集到的卵母细胞多于14个（OR 0.83，95% CI 0.54 - 1.28，p = 0.40）。我们的经验表明，与注射用重组促卵泡素α/β的个性化起始剂量相比，使用算法选择剂量的注射用重组促卵泡素δ达到目标反应的患者比例方面并没有更差结果，且注射用重组促卵泡素δ具有客观性优势。需要更大样本量来证实这些结果。
