Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06339476
Other study ID # Dilara ÜLGER ÖZBEK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.)

Study Design


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)
See also
  Status Clinical Trial Phase
Completed NCT05688995 - COVID-19 Vaccines and the Menstrual Cycle
Completed NCT01927471 - Nutritional and Metabolic Correlates of Ovarian Morphology in Women With Polycystic Ovary Syndrome
Completed NCT00392873 - Increased Calorie Intake to Reverse Energy Deficiency in Exercising Women: Impact on Bone and Menstrual Cyclicity N/A
Completed NCT05083065 - Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine
Recruiting NCT04940013 - Missed Period Pill Study Phase 4
Completed NCT03547453 - Ovarian Ultrasonography for the Clinical Evaluation of Polycystic Ovary Syndrome
Completed NCT04985591 - The Effect of Liposuction on Menses: a Retrospective Study Early Phase 1
Completed NCT04006171 - Comparison of Serum C Type Natriuretic Peptide Levels Between Polycystic Ovary Syndrome Patients and Healthy Women N/A
Completed NCT01555190 - Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone N/A
Active, not recruiting NCT05230316 - Gynecological Symptoms and Health-related Quality of Life in Egyptian Women With SLE
Completed NCT05410314 - Nutritional Supplement Based on Myo-inositol-D-chiro-inositoln in Long-term Survivors of Lymphoma
Withdrawn NCT05518006 - An Investigation of Premama Balance and Its Effects on Hormonal Imbalances N/A
Not yet recruiting NCT05224726 - Platelet Rich Plasma for Uterine Scar N/A
Completed NCT04413058 - Menstrual Cycle Characteristics of Healthcare Professionals
Recruiting NCT05197491 - Women's Menstruation During the Covid-19 Pandemic