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

Oregon Health & Science University (OHSU)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Menstrual Bleeding, Heavy

Treatments: Procedure: Sample Collection and Endometrial Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05862805

OHSU IRB 23749

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Heavy Menstrual Bleeding

Active Comparator group

Description:

Participants with heavy menstrual bleeding will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture.

Treatment:

Procedure: Sample Collection and Endometrial Biopsy

Regular Mensural Bleeding

Active Comparator group

Description:

Participants with normal menstrual bleeding will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture.

Treatment:

Procedure: Sample Collection and Endometrial Biopsy