Menstrual Cycle Abnormal, Menstrual Irregularity
Conditions
Brief summary
A cross-sectional study design was employed, involving 56 premenopausal participants with ages ranging from 20 to 49 years. Serum samples were collected during the early follicular phase, and levels of some biochemicals parameters analyzed.
Detailed description
A cross-sectional study was conducted to investigate the potential relationship between menstrual regularity and the apoptosis marker caspase-cleaved cytokeratin 18 fragment (M30), Asymmetric dimethylarginine (ADMA), and Malondialdehyde (MDA) levels. The investigators screened 80 participants who applied for menstrual irregularity between 2023 February and 2024 March and, in addition to menstrual irregularities, 24 individuals with additional gynecological conditions such as polycystic ovary syndrome (PCOS) and endometriosis were excluded from the study. In the overall study population of 56 subjects aged 20-49 were recruited from, Sivas Cumhuriyet University Faculty of Medicine Research and Practice Hospital, Gynecology and Obstetrics Clinic. Participants were divided into two groups: irregular menstrual cycle (28 participants) and regular menstrual cycle control group (28 participants). While those who met the criteria for menstrual irregularity were included, those with another gynecological disease (PCOS, endometriosis, etc.) and additional diseases (diabetes, insulin resistance, cancer, heart disease, etc.) were excluded from the study. All participants provided written informed consent before participating in the study. The study protocol was approved by the Sivas Cumhuriyet University, Clinical Research Ethics Committee Chairman, 2023-02/06. All procedures were performed in accordance with the ethical standards laid down in the Declaration of Helsinki.
Interventions
DIAGNOSTIC_TESTSerum ADMA, MDA and M30 levels mesurment
Blood samples collected from patienst, only 7 mL
Sponsors
Cumhuriyet University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Intervention model description
In the overall study population of 56 subjects recruited from, Sivas Cumhuriyet University Faculty of Medicine Research and Practice Hospital, Gynecology and Obstetrics Clinic, divided into two groups: irregular menstrual cycle (n=28) and regular menstrual cycle control group (n=28). While those who met the criteria for menstrual irregularity were included, those with another gynecological disease (PCOS, endometriosis, etc.) and additional diseases (diabetes, insulin resistance, cancer, heart disease, etc.) were excluded from the study. All participants provided written informed consent before participating in the study. Participants were asked to report the average length of their menstrual cycle over the past six months, as well as the consistency of cycle length. Menstrual regularity was assessed by self-report using a standardized questionnaire.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Menstrual Irregularity * Being over 18 years of age and not distinguished by age.
Exclusion criteria
* Another gynecological disease (PCOS, endometriosis, etc.) and additional diseases (diabetes, insulin resistance, cancer, heart disease, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADMA, M30 and MDA levels mesurment in the blood serum to compare between patient and control. | not measured in time frame. general (one day) | ADMA, M30 and MDA levels mesured in the blood serum. The most common side effect when blood is taken from the patient is slight bruising and swelling in the arm due to needle sticking. There will be no other serious side effects. |
Countries
Turkey (Türkiye)
Outcome results
None listed