GynePro Medical Centers
GynePro Medical Centers
Rienzi L.,Center for Reproductive Medicine |
Bariani F.,Italian National Institute of Health ISS |
Dalla Zorza M.,Aulss 2 Marca Trevigiana |
Albani E.,Humanitas Research Hospital |
And 7 more authors.
Human Reproduction | Year: 2017
STUDY QUESTION Can traceability of gametes and embryos be ensured during IVF? SUMMARY ANSWER The use of a simple and comprehensive traceability system that includes the most susceptible phases during the IVF process minimizes the risk of mismatches. WHAT IS KNOWN ALREADY Mismatches in IVF are very rare but unfortunately possible with dramatic consequences for both patients and health care professionals. Traceability is thus a fundamental aspect of the treatment. A clear process of patient and cell identification involving witnessing protocols has to be in place in every unit. To identify potential failures in the traceability process and to develop strategies to mitigate the risk of mismatches, previously failure mode and effects analysis (FMEA) has been used effectively. The FMEA approach is however a subjective analysis, strictly related to specific protocols and thus the results are not always widely applicable. To reduce subjectivity and to obtain a widespread comprehensive protocol of traceability, a multicentre centrally coordinated FMEA was performed. STUDY DESIGN, SIZE, DURATION Seven representative Italian centres (three public and four private) were selected. The study had a duration of 21 months (from April 2015 to December 2016) and was centrally coordinated by a team of experts: a risk analysis specialist, an expert embryologist and a specialist in human factor. Principal investigators of each centre were first instructed about proactive risk assessment and FMEA methodology. A multidisciplinary team to perform the FMEA analysis was then formed in each centre. After mapping the traceability process, each team identified the possible causes of mistakes in their protocol. A risk priority number (RPN) for each identified potential failure mode was calculated. The results of the FMEA analyses were centrally investigated and consistent corrective measures suggested. The teams performed new FMEA analyses after the recommended implementations. PARTICIPANTS/MATERIALS, SETTING, METHODS In each centre, this study involved: the laboratory director, the Quality Control & Quality Assurance responsible, Embryologist(s), Gynaecologist(s), Nurse(s) and Administration. The FMEA analyses were performed according to the Joint Commission International. MAIN RESULTS AND THE ROLE OF CHANCE The FMEA teams identified seven main process phases: oocyte collection, sperm collection, gamete processing, insemination, embryo culture, embryo transfer and gamete/embryo cryopreservation. A mean of 19.3 (SD ± 5.8) associated process steps and 41.9 (SD ± 12.4) possible failure modes were recognized per centre. A RPN ≥15 was calculated in a mean of 6.4 steps (range 2-12, SD ± 3.60). A total of 293 failure modes were centrally analysed 45 of which were considered at medium/high risk. After consistent corrective measures implementation and re-evaluation, a significant reduction in the RPNs in all centres (RPN <15 for all steps) was observed. A simple and comprehensive traceability system was designed as the result of the seven FMEA analyses. LIMITATIONS, REASONS FOR CAUTION The validity of FMEA is in general questionable due to the subjectivity of the judgments. The design of this study has however minimized this risk by introducing external experts for the analysis of the FMEA results. Specific situations such as sperm/oocyte donation, import/export and pre-implantation genetic testing were not taken into consideration. Finally, this study is only limited to the analysis of failure modes that may lead to mismatches, other possible procedural mistakes are not accounted for. WIDER IMPLICATIONS OF THE FINDINGS Every single IVF centre should have a clear and reliable protocol for identification of patients and traceability of cells during manipulation. The results of this study can support IVF groups in better recognizing critical steps in their protocols, understanding identification and witnessing process, and in turn enhancing safety by introducing validated corrective measures. STUDY FUNDING/COMPETING INTEREST(S) This study was designed by the Italian Society of Embryology Reproduction and Research (SIERR) and funded by the Italian National Transplant Centre (CNT) of the Italian National Institute of Health (ISS). The authors have no conflicts of interest. TRIAL REGISTRATION NUMBER N/A. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: email@example.com.
Parmegiani L.,Reproductive Medicine Unit |
Cognigni G.E.,Reproductive Medicine Unit |
Ciampaglia W.,Reproductive Medicine Unit |
Pocognoli P.,Reproductive Medicine Unit |
And 2 more authors.
Journal of Assisted Reproduction and Genetics | Year: 2010
Purpose: Hyaluronic Acid (HA) has a role as "physiologic selector" for spermatozoa prior to intracytoplasmic sperm injection (ICSI). The objective of this study is to analyze the results achievable by the introduction of a routine HA-ICSI programme. Methods: We retrospectively observed 293 couples treated with HA-ICSI versus 86 couples treated with conventional PVP-ICSI (historical control group). ICSI was performed on a limited number of oocytes per patient (1-3) according to Italian IVF law at the time of the study. Main outcome measures observed were: fertilization, embryo quality, implantation and pregnancy. Results: This study showed that Injection of HA-bound spermatozoa (HA-ICSI) significantly improves embryo quality and implantation. Conclusions: If wider multi-center randomized studies will confirm these beneficial effects on ICSI outcome, HA could be considered as a routine choice for "physiologic" sperm selection prior to ICSI. © 2009 Springer Science+Business Media, LLC.
Ebner T.,Landes Frauen und Kinderklinik |
Filicori M.,GynePro Medical Centers |
Tews G.,Landes Frauen und Kinderklinik |
Parmegiani L.,GynePro Medical Centers
Andrologia | Year: 2012
Intracytoplasmic sperm injection (ICSI) can be considered the most 'revolutionary' in vitro insemination technique because it has efficiently allowed the treatment of male factor infertility. Although ICSI has been successfully and safely applied worldwide for almost 20 years, currently, we have no real knowledge regarding the hypothetical long-term side effects on ICSI adults, given the increased likelihood of spermatozoa with defective nuclear content fertilising the oocytes. The aim of this review article is to investigate the most recent advances of performing ICSI in the safest possible manner, thus, minimising the theoretical hazards of this procedure. To allow for substantiated recommendation which male gametes to choose for physiological ICSI an updated search was performed in Medline and Embase, from 1996 to June 2011. Recent technical advances allow operators to more or less simulate physiological conditions in the laboratory, reducing potential damage to the gametes. It seems possible to prevent fertilisation by DNA-damaged and chromosomal-unbalanced spermatozoa by selecting ICSI sperm by motility and/or maturation markers such as hyaluronic acid or other zona pellucida receptors. Furthermore, novel non-invasive imaging techniques can be valid tools for helping in the morphological selection of ICSI spermatozoa. © 2011 Blackwell Verlag GmbH.
Parmegiani L.,GynePro Medical Centers |
Cognigni G.E.,GynePro Medical Centers |
Filicori M.,GynePro Medical Centers
Advances in Experimental Medicine and Biology | Year: 2014
The selection of spermatozoa without DNA fragmentation and chromosomal diseases prior to assisted reproductive techniques helps to optimize the outcome of the treatment; in particular, sperm selection prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) is crucial. In fact, although ICSI has been successfully and safely applied worldwide for almost 20 years, at the present time we have no real knowledge regarding the hypothetical long-term side effects on ICSI adults, given the increased likelihood of spermatozoa with defective nuclear content fertilizing oocytes. In the case of DNA damage, the basal sperm DNA fragmentation rate can be significantly reduced by some sperm processing procedures that improve the percentage of spermatozoa with normal chromatin structure by filtering out DNA-damaged spermatozoa. After this first step, new advances in micromanipulation can be performed to choose the "ideal" mature spermatozoa for ICSI, reducing potential damage to the gametes. In fact, it is possible to prevent fertilization by DNA-damaged and chromosomal-unbalanced spermatozoa by selecting ICSI sperm by maturation markers such as hyaluronic acid or other zona pellucida receptors. Furthermore, novel noninvasive imaging techniques can be valid tools for helping in the morphological selection of ICSI spermatozoa. © 2014 Springer Science+Business Media New York.