Status:
UNKNOWN
Investigating the Endocrine-metabolic-immunological Axis During the Female Menstrual Cycle by Functional Genomics
Lead Sponsor:
University of Bonn
Collaborating Sponsors:
University Hospital, Bonn
Radboud University Medical Center
Conditions:
Menstrual Cycle
Eligibility:
All Genders
20-30 years
Brief Summary
As there are fluctuations in the hormonal balance during the menstrual cycle, it is assumed that due to the interaction between the hormonal system and the immune system, some diseases might be worsen...
Detailed Description
Within the menstrual cycle there are strong hormonal fluctuations. Therefore, it is obvious that the interaction between the endocrine system and the immune system play an important role in the progre...
Eligibility Criteria
Inclusion
- Women or men
- Age between 20 and 30 years
- BMI: 18,5 - 25 kg/m2
- Written informed consent to participate in the study
- if applicable: Regular menstruation in the last 6 months
- if applicable: Cycle length between 21 and 35 days for each cycle in the last 6 months (self-reported).
Exclusion
- Smoking
- Mental illness
- Chronic illnesses
- Antibiotic therapy 3 weeks before the start of the study
- Alcohol, medication and/or drug abuse (BTMG-liable or other psychotropic substances)
- Participation in another clinical study at the same time or within the last 30 days
- Hospitalization in the last 3 months
- Inflammatory condition in the last 30 days or during the course of the study
- Other exclusion criteria at the discretion of the physician/investigator
- History of infection with SARS-CoV2 before or during the study period
- Regular physical activity with very high intensity (athletes)
- Coagulation disorders
- Planning a restrictive diet for weight loss or medical reasons in the next 3 months
- Gastrointestinal disease associated with malabsorption (e.g., Crohn's disease)
- Whole blood donation within the last 3 months (women) or last 2 months (men)
- Known infertility
- Infection with Chlamydia in the past
- if applicable: Pregnancy, lactation
- if applicable: Use of any contraceptive (hormonal or chemical contraception) within and during the 6 months prior to study entry. An exception are mechanical contraceptives such as condoms
- if applicable: planning pregnancy in the next 3 months
- if applicable: attempted conception in the past 6 months
- if applicable: smear test with abnormal findings in the past 6 months (without subsequent abnormal findings)
- if applicable: untreated gynecological infection or of the urogenital tract in the last 6 months
- if applicable: gynecological surgery in the last 12 months
- if applicable: current or past other gynecologic complaints
Key Trial Info
Start Date :
November 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 15 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06072391
Start Date
November 3 2021
End Date
June 15 2024
Last Update
October 10 2023
Active Locations (1)
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1
Rheinische Friedrich-Wilhelms-Universität Bonn
Bonn, Germany, 53115