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临床试验/NCT05063942
NCT05063942Unknown不适用

Does Covid-19 Vaccination in Patients Undergoing in Vitro Fertilization Affect the Live Birth Rate of Their First Embryo Transfer Cycle: A Prospective Cohort Study

Shanghai First Maternity and Infant Hospital0 个研究点目标入组 712 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
712
主要终点
live birth rate per transfer

研究概览

简要总结

Since emerging in the last months of 2019, over 127 000 000 individuals have suffered severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection, and the documented death toll from coronavirus disease 2019 (COVID-19) had reached 2788639 individuals globally by the end of March 2021 (CDC, 2021).It is hoped that widespread vaccination will further limit viral spread and shorten the length of the pandemic and its impact on morbidity and mortality. There are currently two vaccines against the new coronavirus: inactivated vaccines and mRNA vaccines.Nationwide anti-COVID-19 vaccination began in China in March 2020, using the inactivated vaccine. By the end of September 2021, 2206.054 million doses (including the first and second doses of the vaccine) of the vaccines have been fulfilled.There is still a lack of real-world data to assist clinicians in counseling their IVF patients regarding the possible impact of recent recovery from COVID infection, or vaccination against it, on the potential for success of ART. We aimed to determine the impact of confirmed COVID-19 immunization on IVF outcomes, by comparing live birth rate of the first transfer cycle in patients undergoing IVF with and without COVID- 19 vaccination.

详细描述

Since emerging in the last months of 2019, over 127 000 000 individuals have suffered severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection, and the documented death toll from coronavirus disease 2019 (COVID-19) had reached 2788639 individuals globally by the end of March 2021 (CDC, 2021).Although a major victory has been achieved in the fight against the epidemic since first case was reported in Wuhan City,, the cumulative death toll is 5,691 by the end of September in China . At the present time, mitigation strategies for controlling the pandemic continue to rely heavily on universal masking, physical distancing, limiting social interactions, and frequent sanitizing measures. It is hoped that widespread vaccination will further limit viral spread and shorten the length of the pandemic and its impact on morbidity and mortality.

There are currently two vaccines against the new coronavirus: inactivated vaccines and mRNA vaccines. Unlike inactivated vaccines, the mRNA vaccine does not use natural pathogens, but artificially synthesizes the gene sequence encoding a specific antigen protein, and then directly injects the mRNA encoding the antigen protein into the human body to induce the immune system to produce antibodies against the new coronavirus. Although some studies have shown that mRNA vaccines do not increase the risk of miscarriage in women, the conclusion is limited due to the lack of non-pregnant women as a control group. At the same time, the impact of inactivated vaccines on female pregnancy is still in a blank state. Nationwide anti-COVID-19 vaccination began in China in March 2020, using the inactivated vaccine vaccine. By the end of September 2021, 2206.054 million doses (including the first and second doses of the vaccine) of the vaccines have been fulfilled. We aimed to determine the impact of confirmed COVID-19 immunization on IVF outcomes, by comparing live birth rate of the first transfer cycle in patients undergoing IVF with and without COVID- 19 vaccination.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age of women <43 years at the time of ovarian stimulation for IVF

排除标准

  • an abnormal uterine cavity shown on hysterosalpingogram or hysteroscopy,
  • moderate or severe endometriosis,
  • Recipient of oocyte donation and
  • Undergoing preimplantation genetic testing
  • Presence of hydrosalpinx or endometrial polyp which is not surgically treated
  • patients with poor ovarian response (less than 3 mature follicles)

结局指标

主要结局

live birth rate per transfer

时间窗: 10 month

A baby born alive after 22 weeks gestation was classified as a live birth

次要结局

  • embryo implantation rate(2month)
  • biochemical pregnancy rate(2 weeks)
  • number of transferable embryos(2weeks)
  • clinical pregnancy rate(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

chen zhi qin

Professor

Shanghai First Maternity and Infant Hospital

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