The Serum Native Thiol (NT)IVFNCT07033429
Effect of Thiol-Disulfide Homeostasis and Ischemia-Modified Albumin Levels on IVF Results in Male Factor Infertility
An observational study of The Serum Native Thiol (NT) and Total Thiol (TT), run by Duzce University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- The Serum Native Thiol (NT), Total Thiol (TT), Serum Disulfide/TT Ratio
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Jun 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Couples in which women aged 23-45 years and undergoing IVF treatment due to male factor and unexplained infertility were enrolled.
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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Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Thiol-Disulfide Homeostasis and Ischemia-Modified Albumin Levels on In Vitro Fertilization Outcomes in Couples With 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.
Read the 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)
- Keywords
- infertility, in vitro fertilization, ischemia-modified albumin, male factor, thiol-disulfide homeostasis, unexplained
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | undergoing IVF due to male factor infertility | |
| control group | undergoing IVF due to unexplained infertility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate (LBR)
live births to the total number of embryo transfer cycles
Measured: 6 months
beta-human chorionic gonadotropin (hCG) positivity
serum ≥ 10 mlU/mL
Measured: 6 months
clinical pregnancy (CP)
the detection of a gestational sac via transvaginal ultrasonography
Measured: 6 months
Secondary outcomes (1)
diagnosing male infertility
The serum native thiol (NT) levels, serum total thiol (TT) levels in males
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Apr 2023
- Primary completion31 Oct 2023
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for The Serum Native Thiol (NT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Yavuzcan, Duzce University
- Investigators
- Müzeyyen Gülnur Özakşit, M.D., Professor, Study director, Ankara Bilkent City Hospital, IVF Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033429
- Sponsor's protocol ID
- E-23-3605
- Acronym
- IVF
- Status last verified
- Apr 2023
- First submitted
- 13 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the data including demographic characteristics and laboratory findings.
Publications
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.
PubMed 34893004Zec 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.
PubMed 36704764Ozdemir 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.
PubMed 32025332
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Thiol-Disulfide Homeostasis and Ischemia-Modified Albumin Levels on In Vitro Fertilization Outcomes in Couples With Male Factor Infertility
- ClinicalTrials.gov ID
- NCT07033429
- Acronym / sponsor ID
- IVF / E-23-3605
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –undergoing IVF due to male factor infertility |
| control group | – | –undergoing IVF due to unexplained infertility |
Who may qualify
- Ages
- 23 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Couples in which women aged 23-45 years and undergoing IVF treatment due to male factor and unexplained infertility were enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Live birth rate (LBR)
Time frame: 6 months
live births to the total number of embryo transfer cycles
beta-human chorionic gonadotropin (hCG) positivity
Time frame: 6 months
serum ≥ 10 mlU/mL
clinical pregnancy (CP)
Time frame: 6 months
the detection of a gestational sac via transvaginal ultrasonography
1 secondary outcome
diagnosing male infertility
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Background: PubMed 34893004Micoogullari 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.
- Background: PubMed 36704764Zec 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.
- Background: PubMed 32025332Ozdemir 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.
- Individual participant dataSharing planned: Yes. All of the data including demographic characteristics and laboratory findings.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Müzeyyen Gülnur Özakşit, M.D., Professor study director
Ankara Bilkent City Hospital, IVF Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Serum Native Thiol (NT) and Total Thiol (TT), run by Duzce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (LBR) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07033429, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.