Exploring the Complex Links Between Menstrual Irregularity and Cellular Markers

Not Applicable

Completed

• Conditions: Menstrual Irregularity; Menstrual Cycle Abnormal
• Interventions: Diagnostic Test: Serum ADMA, MDA and M30 levels mesurment

• Registration Number: NCT06339476
• Lead Sponsor: Cumhuriyet University

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.

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2024-03-10
• Study Completion: 2024-03-24
• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Status Verified: 2024-04
• Study First Posted: 2024-04-01
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serum ADMA, MDA and M30 levels mesurment	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sivas Cumhuriyet University Hospital; 🇹🇷 Sivas, Centre, Turkey