Clinical performance of a specific granulocyte colony stimulating factor ELISA to determine its concentration in follicular fluid as a predictor of implantation success during in vitro fertilization

Abstract

This study aimed to demonstrate the clinical performance of an ultra-sensitive follicular fluid (FF) granulocyte colony stimulating factor (G-CSF) immunoassay to confirm previous work, indicating a correlation between FF G-CSF concentration and live birth potential of the corresponding embryo after in vitro fertilization. This study was a noninterventional, prospective, diagnostic clinical multicentric study conducted between August 2012 and January 2014 with 396 single embryo transfers (SETs) from 278 subjects. During oocyte retrieval, FF was individually collected. Embryo morphology and implantation success were evaluated. The implantation success rate in the high G-CSF group (32.3%) was higher than the overall rate (27.5%). Similarly, for embryos with optimal morphology, implantation success rates were highest among those in the high G-CSF concentration category (34.5%) compared with low (19.6%) and intermediate (29.8%) G-CSF concentration categories. Significant differences in mean G-CSF concentrations were observed between the study sites. To minimize bias, analyses were repeated using data from the center with the largest number of SETs. In alignment with the overall analysis, this center demonstrated a 43% greater probability of implantation for optimal embryos with high G-CSF compared to the general implantation rate among optimal embryos and a 327% increase compared with the implantation rate of optimal embryos with low G-CSF.

Trial registration: ClinicalTrials.gov identifier: NCT02593513.

Trial registration: ClinicalTrials.gov identifier: NCT02593461.

Trial registration: ClinicalTrials.gov identifier: NCT02586272.

摘要

本研究旨在通过超敏感卵泡液（FF）粒细胞集落刺激因子（G-CSF）免疫检测的临床表现来证实之前的工作, 提示FF G-CSF浓度与体外受精后相应胚胎的活产率相关。本研究是一项2012年8月至2014年1月进行的非介入性、前瞻性、诊断性的临床多中心的研究, 共从278名受试者选出396例单胚胎移植（SETs)。提取卵母细胞时, 分别收集FF。评估胚胎形态和成功植入。高G-CSF组植入成功率（32.3%）高于整体成功率（27.5%）。同样, 对于形态最优的胚胎, 与低G-CSF浓度组（19.6%）和中G-CSF浓度组（29.8%）相比植入成功率最高的是高G-CSF浓度组（34.5%）。各研究组间G-CSF平均浓度存在显著差异。为了使偏倚最小化, 使用来自中心的数据和最大的SETs进行重复分析。与整体分析一致, 本中心发现高G-CSF的最佳胚胎植入率较一般的最佳胚胎植入率高43%, 较低G-CSF的最佳胚胎植入率高327%。

The Chinese abstracts are translated by Prof. Dr. Xiangyan Ruan and her team: Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China.

Keywords:

• Granulocyte colony stimulating factor
• in vitro fertilization
• embryo selection

Acknowledgements

LN and CM are respectively MD PhD Student and Research Associate from the F.R.S.-FNRS (Belgium).

Disclosure statement

Financial arrangements of the authors with companies whose products may be related to the present report are listed below, as declared by the authors. H. Tournaye has received a grant from Mithra and has received personal fees for scientific advisory board membership from Finox, ObsEva, AbbfTournott, and Ferring. T. D’Hooghe is an employee of Merck and a part-time employee of University of Leuven. At the time of this study, he was a full-time employee of University of Leuven. He has received grants from Merck and Ferring and financial clinical trial support from Allergan, Roche, and Proteomika. He has been a paid consultant for WHO, Allergan, Astellas, Cartegenia, Bayer, Roche, and Proteomika. G. Verheyen, S. Perrier d’Hauterive, M. Nisolle, C. Munaut, and L. Noel declare no conflicts of interest. J-M. Foidart is the Scientific Advisory Board Chair for IMCYSE and has been a consultant for Mithra and Allergan.

Additional information

Funding

This study was supported by Femalon.