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Completed

NCT Number: NCT07033429

Effect of Thiol-Disulfide Homeostasis and Ischemia-Modified Albumin Levels on IVF Results in Male Factor Infertility

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.

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Key information

Age range

23 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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Exclusion criteria

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.

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Treatment and study plan

Primary outcomes

  1. Live birth rate (LBR)

    Time frame: 6 months

    live births to the total number of embryo transfer cycles

  2. beta-human chorionic gonadotropin (hCG) positivity

    Time frame: 6 months

    serum ≥ 10 mlU/mL

  3. clinical pregnancy (CP)

    Time frame: 6 months

    the detection of a gestational sac via transvaginal ultrasonography

Secondary outcomes

  1. diagnosing male infertility

    Time frame: 6 months

    The serum native thiol (NT) levels, serum total thiol (TT) levels in males

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Official study title

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

Acronym: IVF

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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