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

Mechanisms of Uterine Fluid Absorption During Early Pregnancy

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

Study Overview

• Status: Recruiting
• Conditions: Endometriosis; Endometrioma

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: James Segars, MD; Phone Number: 410-614-2000; Email: jsegars2@jhmi.edu
• Study Contact Backup: Name: Bhuchitra Singh, MD, MPH, MS, MBA; Phone Number: 410-614-2000; Email: bsingh10@jhmi.edu

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30602
      • Not yet recruiting
      • University of Georgia
      • Contact: Xiaoqin Ye, MD, PhD; Email: ye@uga.edu
      • Principal Investigator: Xiaoqin Ye, MD, PhD
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Principal Investigator: James Segars, MD
      • Contact: Samya El Sayed, MD; Email: selsaye4@jh.edu
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Active, not recruiting
      • Rutgers University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Investigators: Study Chair: James Segars, MD, Johns Hopkins University; Study Director: Bhuchitra Singh, MD, MPH, MS, MBA, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Endometriosis; Endometrial biopsy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: IRB00423161; R01HD114750 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No