RecruitingPhase 1Phase 2NCT05862805

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

The Role of Plasminogen Activator Inhibitor-1 (PAI-1), Tissue Plasminogen Activator (tPA), Tissue Factor Pathway Inhibitor (TFPI), and Endometrial Endothelial Cells in Uterine Hemostasis in Humans


Sponsor

Oregon Health and Science University

Enrollment

70 participants

Start Date

Jul 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria1

  • Regularly menstruating participants between 18-45 years of age

Exclusion Criteria8

  • 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

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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.


Locations(1)

OHSU

Portland, Oregon, United States

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NCT05862805


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