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临床试验/NCT05685992
NCT05685992招募中不适用

The Effects and Underlying Mechanisms of Novel Coronavirus Infection on Reproductive Function and Assisted Pregnancy Outcome

Jinling Hospital, China3 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
3
主要终点
Ongoing pregnancy rate

研究概览

简要总结

This study aims to observe the impact of COVID-19 infection on the reproductive function and assisted pregnancy outcome of infertile couples undergoing assisted reproductive technology and to determine which factors are related to the clinical pregnancy rate. A multicenter, prospective, observational cohort study was adopted. Infertile couples who met the selection criteria were included in this study, the SAS anxiety self-rating scale was filled out, the basic situation was observed, and blood samples and related tissues were collected for testing. Relevant reproductive function, laboratory, clinical, and psychological indicators were collected, and the correlation between the above indicators and the outcome of the ART-related pregnancy were analyzed.

详细描述

In this multicenter, prospective, observational cohort study, we included infertile couples based on inclusion criteria. The couples were asked to fill in the SAS anxiety self-rating scale. Basic information about patients' vaccination status, symptoms related to viral infection, menstruation, sexual desire, and sexual function were obtained. Blood samples of couples were collected on the date of diagnosis, the start date of the fresh cycle during assisted reproductive technology treatment, the day of oocyte retrieval, the day of embryo transfer, the day of 14 days, 35 days after embryo transfer, and the day of 70 days of gestation. Follicular fluid, granulosa cells on the day of oocyte retrieval, and embryo culture fluid on the day of embryo transfer were collected. Blood samples and endometrial tissues were collected five days after oocyte retrieval. Blood samples from the menstrual period, endometrial transformation day, and embryo transfer day of the frozen embryo transfer cycle were also collected. Then C-reactive protein, erythrocyte sedimentation rate, procalcitonin and IL-6, granulocyte-macrophage colony-stimulating factor (GM-CSF), TNF-α, VEGF, and other cytokines and chemokines were determined. In addition, fasting blood glucose, insulin, blood lipids, alpha-function, renin-angiotensinase, I-aldosterone, and other susceptibility indicators to COVID-19 infection were tested. Oxygen saturation, malondialdehyde (MDA), HO-1, and SOD oxidative stress indices of the fingertip pulse were determined. An endometrial receptivity gene chip and proteomics detected endometrial tissue. A panel kit for blood vessel and inflammation indicators detected the abortion decidua tissue. Reproductive function indices AMH, INHB, sex hormones, follicle retrieval rate, Gn days, total Gn, endometrial thickness, the incidence of OHSS, semen quality, oocyte maturation rate, fertilization rate, qualified embryo rate, blastocyst formation rate, and other laboratory indices of both men and women were collected. Assisted pregnancy outcome: clinical pregnancy rate, embryo implantation rate, early abortion rate, ongoing pregnancy rate, and other clinical indicators, as well as psychological indicators such as the SAS anxiety scale, were analyzed to determine the correlation between the above indicators and ART-related pregnancy outcome.

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
20 Years 至 42 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with infertility

排除标准

  • Patients with contraindications to pregnancy or assisted reproductive technology

结局指标

主要结局

Ongoing pregnancy rate

时间窗: 1 year

If the fetal sac, fetal bud, and primitive fetal heartbeat are found by vaginal B-ultrasound examination 55-65 days after embryo transfer, the diagnosis of ongoing pregnancy will be made.

次要结局

  • Clinical and laboratory indicators related to male and female reproductive function(1 year)
  • Outcome indicators of assisted pregnancy(1 year)

研究者

发起方
Jinling Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bing Yao

Professor

Jinling Hospital, China

研究点 (3)

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