Exploring the Complex Links Between Menstrual Irregularity and Cellular Markers

NCT06339476 | Completed DMC

• 1 other identifier: Dilara ÜLGER ÖZBEK
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menstrual Irregularity; Menstrual Cycle Abnormal

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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.

Diagnostic Test: Serum ADMA, MDA and M30 levels mesurment

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.

Interventions

Serum ADMA, MDA and M30 levels mesurment DIAGNOSTIC_TEST

Blood samples collected from patienst, only 7 mL

Also known as: Taking a blood samples

Serum ADMA, MDA and M30 levels mesurment

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University Hospital

Sivas, Centre, 58050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Menstruation Disturbances

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D, lecturer

Model Details: In the overall study population of 56 subjects recruited from, Sivas Cumhuriyet University Faculty of Medicine Research and Practice Hospital, Gynecology and Obstetrics Clinic, divided into two groups: irregular menstrual cycle (n=28) and regular menstrual cycle control group (n=28). 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. Participants were asked to report the average length of their menstrual cycle over the past six months, as well as the consistency of cycle length. Menstrual regularity was assessed by self-report using a standardized questionnaire.

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: June 1, 2023
• Primary Completion: March 10, 2024
• Study Completion: March 24, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)