Exploring the Complex Links Between Menstrual Irregularity and Cellular Markers

Menstrual Irregularity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06339476
• Other study ID #: Dilara ÜLGER ÖZBEK
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: March 24, 2024

Study information

• Verified date: April 2024
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 24, 2024
• Est. primary completion date: March 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Menstrual Cycle Abnormal
• Menstrual Irregularity
• Menstruation Disturbances

Intervention

Diagnostic Test:
• Serum ADMA, MDA and M30 levels mesurment
Blood samples collected from patienst, only 7 mL

Locations

Country	Name	City	State
Turkey	Sivas Cumhuriyet University Hospital	Sivas	Centre

Sponsors (1)

Lead Sponsor	Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)