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

NCT ID: NCT07033429

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 122 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-06-01

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Group

undergoing IVF due to male factor infertility

No interventions assigned to this group

control group

undergoing IVF due to unexplained infertility

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duzce University

OTHER

Sponsor Role: lead

Responsible Party

Ali Yavuzcan

M.D., Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Müzeyyen Gülnur Özakşit, M.D., Professor

Role: STUDY_DIRECTOR

Ankara Bilkent City Hospital, IVF Unit

Locations

Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Micoogullari U, Cakici MC, Kilic FU, Kisa E, Ozcift B, Caglayan A, Neselioglu S, Karatas OF, Erel O. Evaluation of the role of thiol / disulfide homeostasis in the etiology of idiopathic male infertility with a novel and automated assay. Syst Biol Reprod Med. 2022 Apr;68(2):162-168. doi: 10.1080/19396368.2021.2003481. Epub 2021 Dec 10.

Reference Type: BACKGROUND

PMID: 34893004 (View on PubMed)

Zec I, Goldstajn MS, Kuna K, Mikus M, Stabile G, Bianco B, Buzzaccarini G, Lagana AS. Oxidative homeostasis in follicular fluid and reproductive outcomes - from bench to bedside. Prz Menopauzalny. 2022 Dec;21(4):276-284. doi: 10.5114/pm.2022.124019. Epub 2022 Dec 30.

Reference Type: BACKGROUND

PMID: 36704764 (View on PubMed)

Ozdemir AZ, Karli P, Neseli Oglu S. Does thiol/disulfide homeostasis affect the number of metaphase 2 oocyte in the treatment of in vitro fertilization? Future Sci OA. 2020 Jan 14;6(2):FSO452. doi: 10.2144/fsoa-2019-0132.

Reference Type: BACKGROUND

PMID: 32025332 (View on PubMed)

Other Identifiers

E-23-3605

Identifier Type: -

Identifier Source: org_study_id