Exploring the Complex Links Between Menstrual Irregularity and Cellular Markers

Exploring the Complex Links Between Menstrual Irregularity and Cellular Markers: A Focus on the Apoptosis Marker M30, the Endothelial Function Marker Asymmetric Dimethylarginine and Malondialdehyde

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.

Study Overview

• Status: Completed
• Conditions: Menstrual Irregularity; Menstrual Cycle Abnormal
• Intervention / Treatment: Diagnostic test: Serum ADMA, MDA and M30 levels mesurment

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Centre
    • Sivas, Centre, Turkey, 58050
      • Sivas Cumhuriyet University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: Serum ADMA, MDA and M30 levels mesurment; Blood samples collected from patienst, only 7 mL; Other Names: Taking a blood samples
No Intervention: diagnosis of the study group; Determination of the patient and control group to be included in the study group by the relevant gynecologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADMA, M30 and MDA levels mesurment in the blood serum to compare between patient and control.	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.	not measured in time frame. general (one day)

Collaborators and Investigators

• Sponsor: Cumhuriyet University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): March 10, 2024
• Study Completion (Actual): March 24, 2024

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances
• Other Study ID Numbers: Dilara ÜLGER ÖZBEK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study will be opened to researchers after it is published internationally

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No