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临床试验/NCT07033429
NCT07033429已完成不适用

The Impact of Thiol-Disulfide Homeostasis and Ischemia-Modified Albumin Levels on In Vitro Fertilization Outcomes in Couples With Male Factor Infertility

Duzce University1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2023年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
122
试验地点
1
主要终点
Live birth rate (LBR)

研究概览

简要总结

Thiol-disulfide Homeostasis (TDH) is essential for physiological functions in the human reproductive system, including antioxidant defense, detoxification, signal transduction, enzymatic regulation, apoptosis, and cellular communication. Ischemia-Modified Albumin (IMA) serves as an indicator of oxidative stress (OS) and is linked to ischemia-reperfusion injury. This study aimed to investigate changes in OS markers, particularly TDH and IMA levels, in couples with male infertility, and to examine the relationship between these markers and in vitro fertilization (IVF) success. Understanding how TDH and IMA levels influence IVF outcomes is crucial for advancing reproductive treatments for couples having diagnosis of infertility.

详细描述

The thiol-disulfide Homeostasis (TDH) is believed to participate in critical physiological functions, including antioxidant defense, detoxification, signal transduction, enzymatic activity regulation, apoptosis, and cellular communication within the human reproductive system. Ischemia-Modified Albumin (IMA) is considered a surrogate marker for oxidative stress (OS) and has also been linked to ischemia-reperfusion injury. The present study was designed to investigate the alteration of OS markers, including TDH and IMA levels, in couples diagnosed with male infertility, and to examine the association between these OS markers and in vitro fertilization (IVF) success. Couples in which women aged 23-45 years and undergoing IVF treatment due to male factor and unexplained infertility will be enrolled. The serum native thiol (NT), total thiol (TT) levels, disulfide levels and disulfide/TT and NT/TT ratios will be compered between two groups. The serum ischemia-modified albumin (IMA) level will also compared between male infertility and unexplained infetility group. TDH related parameters as NT and TT may be useful as a reflection of OS and as potential diagnostic biomarkers for male infertility

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
23 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Couples in which women aged 23-45 years and undergoing IVF treatment due to male factor and unexplained infertility were enrolled.

排除标准

  • Patients with hepatic or renal disease, systemic infections, systemic inflammatory disorders (such as diabetes mellitus, thyroid hormone disorders, rheumatologic, autoimmune, endocrine, neoplastic or other inflammatory conditions), or a diagnosis of endometriosis were excluded from the study. Smokers were excluded. Additionally, women with diminished ovarian reserve (DOR) were also not included in this study.

结局指标

主要结局

Live birth rate (LBR)

时间窗: 6 months

live births to the total number of embryo transfer cycles

beta-human chorionic gonadotropin (hCG) positivity

时间窗: 6 months

serum ≥ 10 mlU/mL

clinical pregnancy (CP)

时间窗: 6 months

the detection of a gestational sac via transvaginal ultrasonography

次要结局

  • diagnosing male infertility(6 months)

研究者

发起方
Duzce University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Yavuzcan

M.D., Professor

Duzce University

研究点 (1)

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