Mechanisms of Uterine Fluid Absorption During Early Pregnancy ( ELF Study)

Mechanisms of Uterine Fluid Absorption During Early Pregnancy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06847685

Enrollment

140

Registered

2025-02-26

Start date

2025-02-01

Completion date

2030-02-01

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrioma, Endometriosis

Keywords

Endometriosis, Endometrial biopsy

Brief summary

The researchers are evaluating mechanisms of uterine fluid absorption during early pregnancy

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. Subject must be a healthy woman between the ages of 18 and 45 years. 2. Women with diagnosed endometriosis or infertility (cases). 3. Women without a diagnosis of endometriosis or infertility (controls). 4. Subject must have regular menstrual cycles. 5. Subject must have a body mass index (BMI) between 18 and 40. 6. Subject must be or have been sexually active or have had a previous vaginal exam that used a speculum. 7. Subject must be able to understand and provide consent to procedures and use/disclosure of protected health information. 8. No history of Chlamydia trachomatis, Mycoplasma genitalium, Neisseria gonorrhoeae, hepatitis B, and HIV. 9. For IVF study subjects, a minimum endometrial thickness of 7mm at the time of sample collection.

Exclusion criteria

1. Pregnant women. 2. Study subjects with endometrial cancer. 3. Study subjects with a history of endometrial ablation. 4. Study subjects with undiagnosed uterine bleeding. 5. Women with reproductive diseases that affect the endometrium (such as fibroids or uterine polyps that distort endometrial cavity). 6. Study subjects with an intrauterine device (IUD).

Design outcomes

Primary

Measure	Time frame	Description
Expression levels of selected ion channels in human endometrium biopsies across the menstrual cycle.	5 years	Immunolocalization of ion channel levels ENaCα, SLC5A1 and SLC5A3 in endometrial tissues.

Secondary

Measure	Time frame	Description
Compare relative protein expression of ENaCα, SLC5A1 and SLC5A3 by immunohistochemistry	5 years	Compare relative protein expression of ENaCα, SLC5A1 and SLC5A3 by immunohistochemistry in the human endometrial biopsies from women with or without endometriosis.

Countries

United States

Contacts

CONTACTJames Segars, MD

jsegars2@jhmi.edu410-614-2000

CONTACTBhuchitra Singh, MD, MPH, MS, MBA

bsingh10@jhmi.edu410-614-2000

STUDY_CHAIRJames Segars, MD

Johns Hopkins University

STUDY_DIRECTORBhuchitra Singh, MD, MPH, MS, MBA