NCT05862805PHASE1, PHASE2RecruitingAccepts Healthy Volunteers

PAI-1, tPA, TFPI and HEECs in Uterine Hemostasis

Oregon Health and Science University

Start Date

7/12/2023

Completion Date

7/1/2026

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.

Eligibility Criteria

Age Range: 18 years to 45 years

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

Interventions

PROCEDURE

Sample Collection and Endometrial Biopsy

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Conditions

Menstrual Bleeding, Heavy

Locations

OHSU

Portland, Oregon 97239

United States