Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05628766 |
| Other study ID # |
SiirtUNIVERSI |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2022 |
| Est. completion date |
April 21, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Siirt University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
