一种新的卵巢刺激个体化工具：使用新型促性腺激素 - 卵泡刺激素 delta 的 CERES 研究结果。

A new instrument to personalize ovarian stimulation: results of the CERES study after using a novel gonadotropin - follitropin delta.

出版信息

Ceska Gynekol. 2021;86(2):86-92. doi: 10.48095/cccg202186.

DOI:10.48095/cccg202186

PMID:34020554

Abstract

UNLABELLED

: Objective: The aim of the study CERES (CzEch REkovelle real life Study) was to gather experience with the use of a novel gonadotrophine, to evaluate the efficacy of follitropin delta in Czech clinical settings and to compare our results with the clinical trial ESTHER-1.

METHODS

Individualized follitropin delta daily dose in µg based on the patient’s anti-Müllerian hormone (AMH) level and body weight (AMH < 15 pmol/ L: 12 µg/ d; AMH > 15 pmol/ L: 0.10–0.19 µg/ kg/ d; max. 2 µg/ d).

RESULTS

A total of 85 women (aged 24-42 years) was included in the study. The average patients age was 32.9 years, the average body weight was 67.8 kg, and the mean level of AMH was 23.2 pmol/ L. There were initiated 85 controlled ovarian stimulations with follitropin delta and 84 egg collections. Forty patients (47%) had optimal number of retrieved eggs (8-14), 75 patients (88%) had embryotransfer, 10 patients (12%) had no embryo suitable for transfer, 65 patients had single embryo transfer and 10 patients had 2 embryos for transfer. There were reported 37 clinical pregnancies (43.5% cPR - clinical pregnancy rate), 30 live births (35.3% LBR - live birth rate), 3 (3.5%) early moderate ovarian hyperstimulation syndroms (OHSS) and no hospitalization due to the treatment.

CONCLUSION

Individualized ovarian stimulation optimizes ovarian response, maintains treatment efficacy and improves safety by reducing OHSS incidence. The results of the Czech population study are fully comparable with the international, randomized, assessor-blinded trial ESTHER-1.

摘要

目的

CERES（捷克 REkovelle 真实研究）的目的是积累使用新型促性腺激素的经验，评估在捷克临床环境中使用卵泡刺激素 delta 的疗效，并将我们的结果与临床试验 ESTHER-1 进行比较。

方法

根据患者的抗苗勒管激素（AMH）水平和体重，个体化给予每日卵泡刺激素 delta 剂量（μg）（AMH<15pmol/L：12μg/d；AMH>15pmol/L：0.10-0.19μg/kg/d；最大 2μg/d）。

结果

共有 85 名（年龄 24-42 岁）女性入组该研究。患者的平均年龄为 32.9 岁，平均体重为 67.8kg，平均 AMH 水平为 23.2pmol/L。共启动 85 次卵泡刺激素 delta 控制性卵巢刺激和 84 次取卵。40 名患者（47%）获得了最佳的取卵数（8-14 枚），75 名患者（88%）进行了胚胎移植，10 名患者（12%）没有适合移植的胚胎，65 名患者进行了单胚胎移植，10 名患者进行了 2 个胚胎移植。报告了 37 例临床妊娠（43.5% cPR-临床妊娠率），30 例活产（35.3% LBR-活产率），3 例（3.5%）早期中度卵巢过度刺激综合征（OHSS），无因治疗而住院的病例。