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临床试验/NCT05302856
NCT05302856Unknown不适用

CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年3月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
CMV antibody ratio serum/semen

研究概览

简要总结

To assess whether the presence of Cytomegalovirus (CMV) Immunoglobulin G (IGG) antibodies in semen is a reliable predictor of male subfertility or infertility.

详细描述

Prospective cohort study performed in the artificial reproductive technology (ART) unit.

The study will evaluate semen and serum samples from the following groups:

  1. Presumably fertile male patients going through ART treatment (for preimplantation genetic testing (PGT) or female indications).
  2. Subfertile/infertile male patients with abnormal semen analysis.
  3. Male patients suffering from unexplained infertility. All samples will be collected on the day of ovum retrieval procedure, and the semen samples will be evaluated only after completing the fertilization process. The samples will be tested for CMV IGG antibodies and testosterone levels in semen and serum. In addition, anti-sperm antibodies will be measured in the serum. The ratio between CMV IGG antibodies in semen and serum will be calculated, and will be compared with presence of hormone profile, semen analysis parameters and ART parameters.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • All male patients addressing the infertility unit in Hadassah Mt Scopus for IVF procedure

排除标准

  • Refusal to participate
  • Male partner utilizing pre cycle frozen sperm sample
  • Donor sperm cycles
  • Surgically retrieved sperm

结局指标

主要结局

CMV antibody ratio serum/semen

时间窗: Through study completion, an average of 1 year

次要结局

未报告次要终点

研究者

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

Chana Adler

Principal Investigator

Hadassah Medical Organization

研究点 (1)

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