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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07033429
Acronym
IVF
Enrollment
122
Registered
2025-06-24
Start date
2023-04-01
Completion date
2025-06-01
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NT/TT Ratio, Serum Disulfide/TT Ratio, Serum Ischemia-modified Albumin (IMA), The Serum Native Thiol (NT), Total Thiol (TT)

Keywords

infertility, in vitro fertilization, ischemia-modified albumin, male factor, thiol-disulfide homeostasis, unexplained

Brief summary

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.

Detailed description

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

Interventions

None listed

Sponsors

Duzce University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
23 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

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

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Live birth rate (LBR)6 monthslive births to the total number of embryo transfer cycles
beta-human chorionic gonadotropin (hCG) positivity6 monthsserum ≥ 10 mlU/mL
clinical pregnancy (CP)6 monthsthe detection of a gestational sac via transvaginal ultrasonography

Secondary

MeasureTime frameDescription
diagnosing male infertility6 monthsThe serum native thiol (NT) levels, serum total thiol (TT) levels in males

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026