menstrual blood
Conditions
Interventions
Group 1: The procedures carried out as part of this study are limited exclusively to the one-time collection of menstrual blood, the collection of venous blood, and the gathering of medical informatio
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Female gender • Age = 18 years • Visit to the gynecology clinic / specialized outpatient clinic (e.g., endometriosis, desire to conceive, gynecological symptoms, or routine check-up) • Willingness to provide menstrual blood and peripheral blood • Ability and willingness to provide written consent to participate in the study and to the use of the samples for research purposes • Collection of relevant clinical context data (e.g., diagnosis, medication, cycle information)
Exclusion criteria
Exclusion criteria: Overall Cohort (Menstrual Blood/Biomarker Study) - Pregnancy or pregnancy within the last 3 months - Lack of capacity to consent - Active severe infection or acute systemic disease at the time of sample collection - Current or recent malignancy-specific therapy (e.g., chemotherapy, immunotherapy, radiation therapy within the last 6 months) - Participation in clinical trials that could significantly influence immune cell activity or biomarker profiles - Doubts or uncertainty regarding basic study eligibility (e.g., lack of clinical data) Additional exclusion criteria – only for endometriosis/cell isolation/functional studies - Systemic chronic diseases with a potential significant impact on immune function or cell quality, e.g.: - relevant autoimmune diseases (excluding endometriosis) - systemic hematological diseases - known severe immunodeficiency - immunosuppressive or systemic anti-inflammatory long-term therapy (e.g., systemic steroids, biologics, immunosuppressants) - Active systemic inflammation / fever - Use of the contraceptive pill - Systemic chronic diseases with a potential impact on the immune system or cell quality (e.g., autoimmune diseases other than endometriosis, hematological diseases, long-term immunosuppressive therapy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Biomarker analysis: Demonstration of a correlation between selected biomarkers in menstrual blood and corresponding parameters in peripheral blood, e.g., estradiol, testosterone, TSH, AMH, and vitamin D. 2) Cell isolation and cultivability - Successful isolation and cultivation of MenSCs and the epithelial cells also contained in menstrual blood. - Proportion of samples from which viable, proliferating cells are obtained. 3) Cellular characterization - Phenotypic characterization of MenSCs and epithelial cells, also depending on the clinical context of the respective donor - Expression of mesenchymal stem cell markers (e.g., CD73, CD90, CD105) and absence of hematopoietic markers (CD34, CD45), or EPCAM, KRT7, CLDN10, and CDH1 for epithelial cells. - Confirmation of the stem cells’ multipotent differentiation potential into at least one target cell type (e.g., endometrial stroma, smooth muscle cells of the myometrium, cardiac muscle). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Methodological Quality & Reproducibility - Standardization of sample collection and processing (including assessment of the influence of cycle day, collection method, and storage duration on cell and biomarker quality) - Determination of yield and quality parameters of the isolated cells (e.g., viability, passability, clonogenicity). 2) Comparative analyses - Comparison of biological properties of MenSCs and epithelial cells between healthy women and patients with endometriosis. - Exploratory analysis of possible stage-dependent differences in endometriosis. 3) Biomarker and matrix evaluation - Investigation of the stability, repeatability, and technical reproducibility of biomarker measurements in menstrual blood. - Comparison of biomarker profiles between menstrual blood and peripheral blood across different measurement time points (if follow-up is possible). 4) Biobank & Long-Term Use - Establishment of a project-specific, pseudonymized biobank of menstrual blood samples, cell lysates, and associated metadata. - Assessment of the feasibility of long-term storage and subsequent reusability of samples. 5) Feasibility & Participation Aspects - Assessment of the acceptance and feasibility of menstrual blood collection among study participants. 6) Documentation of the rate of fully usable samples and data sets | — |
Countries
Germany
Contacts
Public ContactVivien Kmietczyk
Universitätsklinikum Heidelberg, Medizinische Klinik III
Outcome results
None listed