跳至主要内容
临床试验/NCT06339476
NCT06339476已完成不适用

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

Cumhuriyet University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
ADMA, M30 and MDA levels mesurment in the blood serum to compare between patient and control.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Menstrual Irregularity
  • •Being over 18 years of age and not distinguished by age.

排除标准

  • •Another gynecological disease (PCOS, endometriosis, etc.) and additional diseases (diabetes, insulin resistance, cancer, heart disease, etc.)

研究组 & 干预措施

Serum ADMA, MDA and M30 levels mesurment

Experimental

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.

干预措施: Serum ADMA, MDA and M30 levels mesurment (Diagnostic Test)

diagnosis of the study group

No Intervention

Determination of the patient and control group to be included in the study group by the relevant gynecologist.

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilara Ulger Ozbek

Ph.D, lecturer

Cumhuriyet University

研究点 (1)

Loading locations...

相似试验