Spermic Toxicity Test of Medical Devices for Assisted Reproductive Technology

Lian Huan; Han Qianqian; Fu Zhihao; Wang Junzhi

doi:doi:10.11648/j.wjph.20230802.15

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Spermic Toxicity Test of Medical Devices for Assisted Reproductive Technology

Lian Huan, Han Qianqian, Fu Zhihao, Wang Junzhi

Published in World Journal of Public Health (Volume 8, Issue 2)

Received: 7 March 2023 Accepted: 10 April 2023 Published: 15 April 2023

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Abstract

China has been putting great effort to promote the human assisted reproduction technology (ART) but impose a stringent regulation over the market at the same time. Thus, the safety and effectiveness tests at pre-clinical stage became even more important. Human sperm toxicity test can be used to evaluate the potential effects ART products have on human gametes. To provide a thorough summary and analysis over sperm toxicity evaluation of medical devices for ART operation, as well as to forecast its future direction, currently available test methods and evaluation indicators related to human sperm were elaborated here. However, no test can apply for all kinds of products. It especially holds water in ART field. Not mention the resource of human sperm is scarce worldwide. Thus, this method’s weakness and risk points were stated. Besides, possible alternative approaches for further improvement were also provided. The main purpose of pre-clinical tests and the market supervision never is to impede the progress of the industry, but to provide a reliable and robust system that cultivates competent and creative researchers as well as companies. Ultimately, by pulling government, hospital and industry together, we are able to achieve the primal goal of ART, happily having healthy offspring.

Published in	World Journal of Public Health (Volume 8, Issue 2)
DOI	10.11648/j.wjph.20230802.15
Page(s)	78-81
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Assisted Reproductive Technology, Medical Devices, Human Sperm Survival Assay

References

[1]	YY/T 1535-2017, Biological evaluation of human sperm survival test for human in vitro assisted reproductive technology, 2017.
[2]	X. Cui, Summary of the work on assisted reproductive technology. Proceedings of the 9th National Academic Exchange Conference on Diagnosis and Prenatal Diagnosis of Prenatal Diagnosis and New Technology Seminar of Prenatal Diagnosis and Medical Genetics, 2014: 165.
[3]	F. Nie, L. Wu. Effect of targeted care on the psychological status of women undergoing secondary in vitro fertilization-embryo transfer. Journal of Yichun College, 2022, 44 (12): 93-96.
[4]	Quan Ziwei, Liu Xiaoxi. Development and progress of assisted reproductive technology in China under the background of healthy China. Journal of Medical Research, 2022, 51 (10): 6-8.
[5]	Scientific Treatment for Infertility and Aphoria with WHO Standards, Health Consultation Newspaper, Sept. 19, 2003.
[6]	M. Suleman. A brief analysis of the causes of and related factors of gynecological infertility. World Lest Medical Information Abstract, 2018, 18 (23): 50.
[7]	Lu Yue. Meta-analysis of birth defects in offspring by assisted reproductive technology. Hebei North College, 2021.
[8]	Guan Ruiqin, Wang Zhaoxu, Jiang Aili, Ke Linnan. Thoughts on preclinical safety evaluation of gentamicin in assisted reproductive culture solution [J]. Chinese Pharmaceutical Affairs, 2022, 36 (12): 1377-1382.
[9]	Management measures for human assisted reproductive technology. Bulletin of The State Council of the People's Republic of China, 2002 (06): 25-26.
[10]	Management method of human sperm bank. Judicial Business, 2001 (19): 6-11.
[11]	Basic criteria and technical specifications for the human sperm bank. Chinese Journal of Reproductive Health, 2004 (02): 68-71.
[12]	Sun Xue, Han Qianqian. Industry and supervision status of medical devices for human assisted reproductive technology in China. Chinese Journal of Medical Devices, 2021, 45 (06): 591-593 + 598.
[13]	Hu Xinping, Shi Jiayu. Problems and improvement of genome editing in China. Economic and Trade Law Review, 2022 (01): 19-37.
[14]	Hu Linli, Sun Yingpu. Total quality management of the clinical techniques for assisted reproduction. The Chinese Journal of Practical Gynecology and Obstetrics, 2018, 34 (06): 581-583.
[15]	Shi Jianfeng, Han Qianqian, Wang Chunren. Ellement analysis affecting the standardization of in vitro mouse embryo assay [J]. Chinese Journal of Comparative Medicine, 2017, 27 (07): 102-106.
[16]	Guidelines for technical review of fluid registration for in vitro assisted reproductive technology in humans. China Pharmaceutical Biotechnology, 2018, No. 18.
[17]	Li Kun, Sun Peibei, Li Rui, Zheng Dongwang, Wang Yayan, Ni Ya. Establishment of a new method of sperm selection and study of related regulation mechanism. Paper Abstract of the 15th National Academic Conference of the Chinese Pharmacological Association. [Publisher unknown], 2019: 86.
[18]	Rao Jinpeng, Qiu Feng, Cai Yiting, Jin Fan, Jin Min. Research on the operation of microinjection system in new in vitro fertilization laboratory. Experimental techniques and management, 2019, 36 (09): 82-86.
[19]	Zhou Xiuqin, Chen Cirong, Zhou Linrong, Yan Qiuxia, Guo Xiaoyan, Chen Runqiang, Xian Yingjie. Effect of the number of forward-moving sperm on the pregnancy rate of artificial insemination after semen optimization. International Journal of Laboratory Medicine, 2018, 39 (18): 2317-2319.
[20]	Wu Zhongning, Yuan Siping, Cai Huifeng, Wang Xiaobo, Zhu Junquan. Observation of sperm motility and selection and application of diluent. Scientific fish farming, 2018 (11): 55-56.
[21]	Yao Zhiwei. Effect of sperm culture medium and human seminal plasma on sperm motility parameters in urine recovery. Chinese Male Science, 2002 (05): 375.
[22]	Huang Zhenqiu, Chen Qiaoer, Ye Jialing, Yang Ning, Huang Jianchu, Zheng Hongzhi, Zhou Xiude. Relationship between recovered sperm activity rate and resting time. Journal of Men's Studies, 1991 (04): 227-228.
[23]	Shi Xiao, Wang Ting, Zhou Yao, Liu Li, Zhan Xiaomin, Chen Simei, and Quan Song. Effects of in vitro manipulation on human sperm motility parameters and intracellular Roxygen clusters. International Journal of Reproductive Health / Family Planning, 2016, 35 (05): 369-371.
[24]	Caroppo Ettore. Understanding sperm motility regulation: it’s a long road ahead. Fertility and Sterility, 2020 (prepublish).
[25]	Shang Xuejun, Ye Zhangqun, Xiong Chengliang, Huang Donghui, Wang Yongmei. Analysis of changes in motility caused by reactive oxygen species. Chinese masculinity, 2003 (06): 439-442.
[26]	Zhang Ming, bright red, Zhu Qing, Hou Rong, Zheng Hongpei. Progress in mammalian sperm quality assessment methods. Sichuan Animal, 2007 (01): 230-234.
[27]	Fan Ni. Comparison of the effects of manual and computer-assisted analysis in semen detection. Grassroots Medical Forum, 2020, 24 (04): 500-501.
[28]	Jing Cancan. Performance evaluation of a computer-assisted semen analysis system. The World's Latest Medical Information Abstract, 2017, 17 (37): 120-123.
[29]	Yang Guobin, Wang Dayong, Zhang Yanmei, Cui Yingxia, Yao Bing. On ethical issues in assisted reproductive technology. Medical Graduate Journal, 2009, 22 (10): 1036-1038.
[30]	Zhu Chenjing. Ethical thoughts on the development and application of assisted reproductive technology. Chinese Medical Ethics, 2009, 22 (01): 123-124 +132.
[31]	Jiang Baisheng, Qian Jierong. Ethical issues regarding assisted reproductive technology in humans. Chinese Journal of Family Planning, 2006 (01): 32-35.
[32]	Ma Yuhan, Liu Ruizhi, Xu Zongge, Zhang Hongguo, Li Zhe. On the relationship between sperm morphology and sperm motility parameters. Chinese Journal of Male Science, 2006 (07): 590-593.
[33]	Chen Zhenwen, Gu Longjie. Standardization of semen analysis and assessment of semen quality — WHO Laboratory Manual of human semen Examination and Treatment (5th edition) was published. Chinese Journal of Family Planning, 2012, 20 (01): 58-62.
[34]	Guo Ping, Wu Qing, Chen Yongxia, Yang Jianbo, Xing Jun, Wu Jingsheng. Study on the sperm motility characteristics of Meishan pig boars using a computer-assisted semen analysis system. Jiangsu Agricultural Science, 2019, 47 (02): 165-168.
[35]	Morrell J M, Wallgren M. Colloid centrifugation of boar semen. Reproduction in domestic animals = Zuchthygiene, 2011, 46 Suppl 2.
[36]	H. Henning, T. T. Ngo, D. Waberski. Centrifugation stress reduces the responsiveness of spermatozoa to a capacitation stimulus in in vitro-aged semen. Andrology, 2015, 3 (5).
[37]	Wang Xiaowei, Gu Yiqun, Zhou Fang, Liang Xiaowei, Xu Jianfeng, Lu Wenhong. Evaluation method of commonly used instruments to evaluate sperm concentration. Journal of Reproductive Medicine, 2019, 28 (07): 805-811.

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APA Style

Lian Huan, Han Qianqian, Fu Zhihao, Wang Junzhi. (2023). Spermic Toxicity Test of Medical Devices for Assisted Reproductive Technology. World Journal of Public Health, 8(2), 78-81. https://doi.org/10.11648/j.wjph.20230802.15

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ACS Style

Lian Huan; Han Qianqian; Fu Zhihao; Wang Junzhi. Spermic Toxicity Test of Medical Devices for Assisted Reproductive Technology. World J. Public Health 2023, 8(2), 78-81. doi: 10.11648/j.wjph.20230802.15

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AMA Style

Lian Huan, Han Qianqian, Fu Zhihao, Wang Junzhi. Spermic Toxicity Test of Medical Devices for Assisted Reproductive Technology. World J Public Health. 2023;8(2):78-81. doi: 10.11648/j.wjph.20230802.15

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@article{10.11648/j.wjph.20230802.15,
  author = {Lian Huan and Han Qianqian and Fu Zhihao and Wang Junzhi},
  title = {Spermic Toxicity Test of Medical Devices for Assisted Reproductive Technology},
  journal = {World Journal of Public Health},
  volume = {8},
  number = {2},
  pages = {78-81},
  doi = {10.11648/j.wjph.20230802.15},
  url = {https://doi.org/10.11648/j.wjph.20230802.15},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.wjph.20230802.15},
  abstract = {China has been putting great effort to promote the human assisted reproduction technology (ART) but impose a stringent regulation over the market at the same time. Thus, the safety and effectiveness tests at pre-clinical stage became even more important. Human sperm toxicity test can be used to evaluate the potential effects ART products have on human gametes. To provide a thorough summary and analysis over sperm toxicity evaluation of medical devices for ART operation, as well as to forecast its future direction, currently available test methods and evaluation indicators related to human sperm were elaborated here. However, no test can apply for all kinds of products. It especially holds water in ART field. Not mention the resource of human sperm is scarce worldwide. Thus, this method’s weakness and risk points were stated. Besides, possible alternative approaches for further improvement were also provided. The main purpose of pre-clinical tests and the market supervision never is to impede the progress of the industry, but to provide a reliable and robust system that cultivates competent and creative researchers as well as companies. Ultimately, by pulling government, hospital and industry together, we are able to achieve the primal goal of ART, happily having healthy offspring.},
 year = {2023}
}

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TY - JOUR
T1 - Spermic Toxicity Test of Medical Devices for Assisted Reproductive Technology
AU - Lian Huan
AU - Han Qianqian
AU - Fu Zhihao
AU - Wang Junzhi
Y1 - 2023/04/15
PY - 2023
N1 - https://doi.org/10.11648/j.wjph.20230802.15
DO - 10.11648/j.wjph.20230802.15
T2 - World Journal of Public Health
JF - World Journal of Public Health
JO - World Journal of Public Health
SP - 78
EP - 81
PB - Science Publishing Group
SN - 2637-6059
UR - https://doi.org/10.11648/j.wjph.20230802.15
AB - China has been putting great effort to promote the human assisted reproduction technology (ART) but impose a stringent regulation over the market at the same time. Thus, the safety and effectiveness tests at pre-clinical stage became even more important. Human sperm toxicity test can be used to evaluate the potential effects ART products have on human gametes. To provide a thorough summary and analysis over sperm toxicity evaluation of medical devices for ART operation, as well as to forecast its future direction, currently available test methods and evaluation indicators related to human sperm were elaborated here. However, no test can apply for all kinds of products. It especially holds water in ART field. Not mention the resource of human sperm is scarce worldwide. Thus, this method’s weakness and risk points were stated. Besides, possible alternative approaches for further improvement were also provided. The main purpose of pre-clinical tests and the market supervision never is to impede the progress of the industry, but to provide a reliable and robust system that cultivates competent and creative researchers as well as companies. Ultimately, by pulling government, hospital and industry together, we are able to achieve the primal goal of ART, happily having healthy offspring.
VL - 8
IS - 2
ER -

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Author Information

Lian Huan

Department of Medical Devices, National Institutes for Food and Drug Control, Beijing, China
Han Qianqian

Department of Medical Devices, National Institutes for Food and Drug Control, Beijing, China
Fu Zhihao

Department of Medical Devices, National Institutes for Food and Drug Control, Beijing, China
Wang Junzhi

Department of Medical Devices, National Institutes for Food and Drug Control, Beijing, China

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Plain Text BibTeX RIS

APA Style

Lian Huan, Han Qianqian, Fu Zhihao, Wang Junzhi. (2023). Spermic Toxicity Test of Medical Devices for Assisted Reproductive Technology. World Journal of Public Health, 8(2), 78-81. https://doi.org/10.11648/j.wjph.20230802.15

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ACS Style

Lian Huan; Han Qianqian; Fu Zhihao; Wang Junzhi. Spermic Toxicity Test of Medical Devices for Assisted Reproductive Technology. World J. Public Health 2023, 8(2), 78-81. doi: 10.11648/j.wjph.20230802.15

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AMA Style

Lian Huan, Han Qianqian, Fu Zhihao, Wang Junzhi. Spermic Toxicity Test of Medical Devices for Assisted Reproductive Technology. World J Public Health. 2023;8(2):78-81. doi: 10.11648/j.wjph.20230802.15

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@article{10.11648/j.wjph.20230802.15,
  author = {Lian Huan and Han Qianqian and Fu Zhihao and Wang Junzhi},
  title = {Spermic Toxicity Test of Medical Devices for Assisted Reproductive Technology},
  journal = {World Journal of Public Health},
  volume = {8},
  number = {2},
  pages = {78-81},
  doi = {10.11648/j.wjph.20230802.15},
  url = {https://doi.org/10.11648/j.wjph.20230802.15},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.wjph.20230802.15},
  abstract = {China has been putting great effort to promote the human assisted reproduction technology (ART) but impose a stringent regulation over the market at the same time. Thus, the safety and effectiveness tests at pre-clinical stage became even more important. Human sperm toxicity test can be used to evaluate the potential effects ART products have on human gametes. To provide a thorough summary and analysis over sperm toxicity evaluation of medical devices for ART operation, as well as to forecast its future direction, currently available test methods and evaluation indicators related to human sperm were elaborated here. However, no test can apply for all kinds of products. It especially holds water in ART field. Not mention the resource of human sperm is scarce worldwide. Thus, this method’s weakness and risk points were stated. Besides, possible alternative approaches for further improvement were also provided. The main purpose of pre-clinical tests and the market supervision never is to impede the progress of the industry, but to provide a reliable and robust system that cultivates competent and creative researchers as well as companies. Ultimately, by pulling government, hospital and industry together, we are able to achieve the primal goal of ART, happily having healthy offspring.},
 year = {2023}
}

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