Menstrual Bleeding, Heavy
Conditions
Brief summary
The purpose of the study is to learn more about the role of blood clotting factor proteins and cells in menstrual (period) bleeding. The investigators are hoping to identify differences in these proteins and cells in the menstrual blood of individuals with heavy periods compared to menstruating individuals who do not have heavy periods.
Detailed description
The purpose of this study is to learn if human endometrial endothelial cells (HEECs) regulate human uterine hemostasis through the up and down-regulation of pro- and anti-coagulant factors in menstrual blood including PAI-1, factor XI (FXI)-PAI-1 complex, tPA, and TFPI. This study will enroll participants with heavy menstrual bleeding (HMB) and participants without HMB. Coagulation factors will be measured in menstrual blood and mRNA for these factors will be quantified from cultured HEECS from endometrial biopsies and compared between groups.
Interventions
PROCEDURESample Collection and Endometrial Biopsy
Participants will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture.
Sponsors
Oregon Health and Science University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Regularly menstruating participants between 18-45 years of age
Exclusion criteria
* Pregnancy within 3 months of enrollment * Lactating at the time of enrollment * Hormonal contraceptive use or use of the copper intrauterine device (IUD) * Antifibrinolytic use * Inherited or acquired bleeding disorder or anticoagulant use * Known structural cause of HMB * Inability to complete PBACs * Unwilling to refrain from sexual intercourse for the two weeks prior to endometrial biopsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number of mRNA copies from HEEC culture of tPA | Enrollment to 60 days | The total number of mRNA copies of tPA in HEEC cultures from enrollment to 60 days. |
| Total number of mRNA copies from HEEC culture of PAI-1 | Enrollment to 60 days | The total number of mRNA copies of PAI-1 in HEEC cultures from enrollment to 60 days. |
| Total number of mRNA copies from HEEC culture of TFPI | Enrollment to 60 days | The total number of mRNA copies of TFPI in HEEC cultures from enrollment to 60 days. |
| Change in the numerical score of Pictorial Blood Loss Assessment | Enrollment to 60 days | The change in the Pictorial Blood Loss Assessment Charts (PBACs) from baseline to 60 days. Participants will be asked to tally the number of pads and tampons, the level of saturation of menstrual blood on the pads or tampons, and the number of clots. Scores greater than 100 are considered diagnostic of heavy menstrual bleeding. |
Countries
United States
Contacts
Primary ContactWomen's Health Research Unit Department of Ob/Gyn
Outcome results
None listed