NCT06339476

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Cumhuriyet University · Academic / Other
• Sex: Female
• Age: 20 Years – 49 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Serum ADMA, MDA and M30 levels mesurment	Blood samples collected from patienst, only 7 mL

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-03-10
• Completion: 2024-03-24
• First posted: 2024-04-01
• Last updated: 2024-04-03

Locations

1 site across 1 country: Turkey (Türkiye)