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

Recruiting

• Conditions: Endometriosis; Endometrioma

• Registration Number: NCT06847685
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-01
• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-21
• Study First Posted: 2025-02-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Primary Completion: 2029-02-01
• Study Completion: 2030-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

University of Georgia; 🇺🇸 Athens, Georgia, United States

Rutgers University; 🇺🇸 Piscataway, New Jersey, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States