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

NCT06847685 | Recruiting

• 2 other identifiers: IRB00423161R01HD114750
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Endometrioma; Endometriosis

Keywords

Endometriosis; Endometrial biopsy

Outcome Measures

Primary Outcomes (1)

• Expression levels of selected ion channels in human endometrium biopsies across the menstrual cycle.

  Immunolocalization of ion channel levels ENaCα, SLC5A1 and SLC5A3 in endometrial tissues.

  5 years

Secondary Outcomes (1)

• Compare relative protein expression of ENaCα, SLC5A1 and SLC5A3 by immunohistochemistry

  5 years

Study Arms (2)

Women between the ages of 18 and 45 years with or without endometriosis

50 women with endometriosis (cases) and 50 without endometriosis (controls)

Women between the ages of 18 and 45 years with or without endometrial cavity fluid undergoing IVF

20 women with endometrial lumen fluid and 20 women without endometrial lumen fluid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women between the ages of 18-45 with or without endometriosis.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

University of Georgia

Athens, Georgia, 30602, United States

NOT YET RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Rutgers University

Piscataway, New Jersey, 08854, United States

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Endometrial biopsy samples

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• James Segars, MD

  Johns Hopkins University

  STUDY CHAIR

• Bhuchitra Singh, MD, MPH, MS, MBA

  Johns Hopkins University

  STUDY DIRECTOR

Central Study Contacts

James Segars, MD

CONTACT

410-614-2000; jsegars2@jhmi.edu

Bhuchitra Singh, MD, MPH, MS, MBA

CONTACT

410-614-2000; bsingh10@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)