Exploring the Complex Links Between Menstrual Irregularity and Cellular Markers

NCT ID: NCT06339476

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-03-24

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.

Conditions

Menstrual Irregularity; Menstrual Cycle Abnormal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Serum ADMA, MDA and M30 levels mesurment

With the permission of the participants, 7 ml of venous, fasting blood samples were collected during the early follicular phase. In the blood serum of the participants, M30, ADMA, and MDA levels were measured by using commercial ELISA test kits.

Group Type: EXPERIMENTAL

Serum ADMA, MDA and M30 levels mesurment

Intervention Type: DIAGNOSTIC_TEST

Blood samples collected from patienst, only 7 mL

diagnosis of the study group

Determination of the patient and control group to be included in the study group by the relevant gynecologist.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Serum ADMA, MDA and M30 levels mesurment

Blood samples collected from patienst, only 7 mL

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Taking a blood samples

Eligibility Criteria

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.)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

Dilara Ulger Ozbek

Ph.D, lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sivas Cumhuriyet University Hospital

Sivas, Centre, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Dilara ÜLGER ÖZBEK

Identifier Type: -

Identifier Source: org_study_id