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

NCT07033429 | Completed

• 1 other identifier: E-23-3605
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Live birth rate (LBR)

  live births to the total number of embryo transfer cycles

  6 months

• beta-human chorionic gonadotropin (hCG) positivity

  serum ≥ 10 mlU/mL

  6 months

• clinical pregnancy (CP)

  the detection of a gestational sac via transvaginal ultrasonography

  6 months

Secondary Outcomes (1)

• diagnosing male infertility

  6 months

Study Arms (2)

Study Group

undergoing IVF due to male factor infertility

control group

undergoing IVF due to unexplained infertility

Eligibility Criteria

• Age: 23 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 34893004 BACKGROUND

• 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.

  PMID: 36704764 BACKGROUND

• 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.

  PMID: 32025332 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples were collected from the males on the day of oocyte pick-up. Blood samples were drawn from the antecubital vein and transferred into gel-based biochemistry tubes for the determination of TDH, IMA and other biochemical parameters.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Müzeyyen Gülnur Özakşit, M.D., Professor

  Ankara Bilkent City Hospital, IVF Unit

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Professor

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: April 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: June 1, 2025
• Last Updated: June 24, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From the beginning of study up to now.

Locations

TU (1)