Skip to main content
OpenTrials
Completed

NCT Number: NCT06339476

Exploring the Complex Links Between Menstrual Irregularity and Cellular Markers

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sivas Cumhuriyet University Hospital

Sivas, Centre, 58050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Serum ADMA, MDA and M30 levels mesurment

Diagnostic Test

Blood samples collected from patienst, only 7 mL

Other names: Taking a blood samples

Primary outcomes

  1. ADMA, M30 and MDA levels mesurment in the blood serum to compare between patient and control.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2024
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.