Thiol/Disulphide Homeostasis in Unexplained Infertility

Sponsor
Siirt University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05628766
Collaborator
(none)
82
3.3

Study Details

Study Description

Brief Summary

The aim in this study is to determine whether there is a relationship between Thiol / Disulphide levels in primary infertile patients and comparing them with infertile patients and the control group. For this purpose, 41 women followed up with the diagnosis of primary infertility in Siirt Training and Research Hospital between November 2022 and January 2023 will be included in the study. The same number of (n:41) non-infertile control women will be included. Age, pregnancy history and medical history of both groups will be recorded. FSH, LH, E2, TSH, and prolactin levels taken routinely in these patients will be examined. Thiol/disulphide levels in the blood will be checked by taking whole blood from these patients. In the light of the information thus obtained, the investigator plan to determine whether there is a relationship between oxidant/antioxidant balance in primary infertile patients.

Condition or Disease Intervention/Treatment Phase
  • Other: complete blood count

Detailed Description

Reactive oxygen species (ROS) are products of normal cellular metabolism and consist of oxygen ions, free radicals and peroxides. Adding an electron to oxygen creates the superoxide anion radical, which can then be converted to a hydroxyl radical, peroxyl radical, or hydrogen peroxide. Free radicals try to participate in chemical reactions that free themselves of their unpaired electrons and result in oxidation. Natural antioxidants found in the body include catalase, glutathione peroxidase, superoxide dismutase and glutathione reductase, vitamins C and E, ferritin, and transferrin. Other lifestyle factors such as smoking, diet, illness, pollution, stress, alcohol, and allergies also contribute to increased levels of free radicals, suggesting that these factors have a negative impact on female fertility, potentially through the formation of excessive oxidative stress.

Excessive accumulation of ROS can damage cells, proteins, DNA and lipids; therefore, ROS levels are regulated by antioxidant mechanisms in the organism. A shift in the direction of ROS in this balance is called oxidative stress (OS). ROS produced in the follicle have important roles in folliculogenesis and ovulation. Granulosa cells produce antioxidants to protect oocytes from the harmful effects of excess ROS. OS has been implicated as an etiopathogenetic factor in female infertility. The number of studies examining the role of OS in the etiopathogenesis of infertility has increased in recent years, and it has been suggested that increased OS and/or decreased antioxidant defense mechanisms may contribute to infertility-related conditions.

One of the defense mechanisms against OS in humans is the thiol redox reaction. The thiol consists of a sulfhydryl group, and under OS conditions these functional groups form reversible disulfide bridges. These bonds bring about functional and structural changes in proteins. Disulfide bonds are reduced to thiol groups through antioxidant mechanisms, thereby providing thiol/disulfide homeostasis. Thus, disulfide bridges are thought to be a marker of OS, while thiols are suggested to be members of the antioxidant system. Only one side of this equilibrium has been measured by Ellman (1979), whereas in recent years both sides of the thiol/disulfide equilibrium can be measured by the Erel and Neselioğlu assay method, allowing a full assessment of the thiol/disulfide status.

Dynamic thiol/disulfide homeostasis, a recently identified marker of OS, is thought to have critical roles in pathological processes in various vital processes such as folliculogenesis and ovulation.

n the literature review, there are studies investigating the relationship between infertility and oxidant/antioxidants. However, measurements require measuring a large number of parameters and many separate biomarkers. The thiol/disulfide balance is beneficial in terms of showing the oxidant/antioxidant balance in total. It was not possible to measure this balance simultaneously on both sides in the method measuring the thiol/disulfide balance by Newman in 1979. In recent years, it has become possible to measure the serum Thiol/disulfide balance bilaterally with the automatic spectrophotometric method described by Erel and Neşelioğlu. This study aims to investigate whether there is a relationship by measuring the Total oxidant/antioxidant load with the Thiol/disulfide method in patients with unexplained infertility, to investigate the relationship between thiol/disulfide homeostasis and impaired ovulation and fertility, and to analyze the potential pathogenetic mechanism.

Study Design

Study Type:
Observational
Anticipated Enrollment :
82 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Role of Thiol/Disulphide Homeostasis in Unexplained Primary Infertile Patients
Anticipated Study Start Date :
Dec 20, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Women diagnosed with primary infertility (n:41)

Women which followed up with infertility of unknown cause.

Other: complete blood count
Thiol/disulphide levels in the blood will be checked by taking complete blood count

Control group ( n:41)

Healthy women who are not infertile

Other: complete blood count
Thiol/disulphide levels in the blood will be checked by taking complete blood count

Outcome Measures

Primary Outcome Measures

  1. Measuring the total oxidant/antioxidant load with the Thiol/disulfide method in patients with unexplained infertility ["through study completion, an average of 4 months]

    To determine whether there is a relationship between oxidant/ antioxidant balance in primary infertile patients by looking at Thiol/disulphide blood levels in both groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:
  • Patients diagnosed with primary infertility

  • Patients between the age of 18-35

Exclusion Criteria:
  • Active hypertension

  • Chronic liver or kidney failure history

  • Coronary artery disease

  • Acute infection (within 14 days)

  • Any chronic inflammatory disease

  • Presence of autoimmune disease

  • Known malignancy

  • Inflammatory bowel disease

  • Hormonal contraception

  • Smoking

  • alcohol use

  • Drug use

  • Patients with tubal infertility

  • Partner with abnormal spermiogram

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Siirt University

Investigators

  • Study Director: Şerif Aksin, assoc.Prof, Siirt University Medical Faculty Obstetrics and Gynecology Departmant

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Serif Aksin, associate professor, Siirt University
ClinicalTrials.gov Identifier:
NCT05628766
Other Study ID Numbers:
  • SiirtUNIVERSI
First Posted:
Nov 29, 2022
Last Update Posted:
Dec 6, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 6, 2022