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临床试验/NCT04822012
NCT04822012Unknown不适用

Anti COVID-19 Antibodies in Spermatic Fluid and Follicular Fluid

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Follicular - Serum Anti COVID-19 antibody (Immunoglobulin G) ratio

研究概览

简要总结

Patients going through an in vitro fertilization cycle will be asked to participate . Patients will be asked for their COVID-19 exposure : post confirmed disease/post vaccine/not exposed to disease or vaccine . Patients will provide the fluids which are not required , once fertilization process is completed. Patients will also provide 5ml blood sample by the day of procedure. Anti COVID-19 immunoglobulin G type antibodies will be measured in all samples . Data regarding age, date of infection/vaccine will be collected . Progesterone and Estrogen will be measured in female patients' samples and Perlecan level will be measured in follicular fluid.

详细描述

Patients going through an in vitro fertilization cycle will be asked to participate . Patients will be asked for their COVID-19 exposure : post confirmed disease/post vaccine/not exposed to disease or vaccine . Patients will provide the fluids which are not required in the day of egg retrieval : the follicular fluid remaining after isolation of the egg and spermatic fluid only, if not utilized for fertilization. The fluids will be collected once fertilization process is completed. Patients will also provide 5ml blood sample by the day of procedure. Anti COVID-19 immunoglobulin G type antibodies will be measured in all samples . Data regarding age, date of infection/vaccine will be collected as well as indication for treatment, Estradiol level before the egg retrieval, number of eggs collected and the triggering ovulation modality . Progesterone and Estrogen will be measured in female patients' samples (follicular fluid and serum). Perlecan level will be measured in follicular fluid.

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 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Planned egg retrieval procedure (including egg preservation)
  • Negative PCR for SARS-Cov-19 in the week before egg retrival
  • Informed consent

排除标准

  • Positive PCR for SARS-Cov-19 in the week before egg retrival
  • expected retrival of 1-3 eggs

结局指标

主要结局

Follicular - Serum Anti COVID-19 antibody (Immunoglobulin G) ratio

时间窗: Through study completion, expected 2 months

The relationship between antibodies to COVID-19 in serum to follicular fluid in female patients going through an egg retrieval

Spermatic fluid- Serum Anti COVID-19 antibody (Immunoglobulin G) ratio

时间窗: Through study completion, expected 2 months

The relationship between antibodies to COVID-19 in serum to spermatic fluid in male patients going through in vitro fertilization treatment

次要结局

  • Follicular fluid Estradiol level (pmol/L)(Through study completion, expected 2 months)
  • Follicular fluid Progesterone level (nmol/L)(Through study completion, expected 2 months)
  • Follicular fluid Perlecan level (nmol/L)(Through study completion, expected 2 months)

研究者

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

Anat Hershko Klement

Unit director

Meir Medical Center

研究点 (1)

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