Actively Recruiting
Mechanisms of Uterine Fluid Absorption During Early Pregnancy
Led by Johns Hopkins University · Updated on 2026-03-09
140
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the processes involved in how uterine fluid is absorbed during early pregnancy. This observational study focuses on women aged 18 to 45, including those with endometriosis, infertility, or without these conditions, to better understand the biology of the uterus in these groups. The research is sponsored by Johns Hopkins University and aims to provide insights into the menstrual cycle and uterine health. The study involves two groups: 50 women diagnosed with endometriosis and 50 without, as well as 20 women with endometrial lumen fluid and 20 without, all undergoing evaluation possibly during procedures such as IVF. The researchers will analyze the expression levels of selected ion channels and proteins in endometrium tissue samples collected across the menstrual cycle over a five-year period. Participants will undergo biopsies of the endometrium to measure specific proteins and ion channels related to uterine fluid absorption. The main outcome measure is the expression levels of selected ion channels in tissue samples. Secondary measures include protein expression comparisons using immunohistochemistry. The study includes follow-up and monitoring over five years, with assessments of menstrual cycle regularity, body mass index, and infection history to ensure safety and data quality.
CONDITIONS
Brief Title
Mechanisms of Uterine Fluid Absorption During Early Pregnancy ( ELF Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy women between the ages of 18 and 45 years
- Diagnosed with endometriosis or infertility (cases)
- Without diagnosis of endometriosis or infertility (controls)
- Regular menstrual cycles
- Body mass index (BMI) between 18 and 40
- Sexually active or have had a previous vaginal exam using a speculum
- Able to understand and provide consent for procedures and health information use
- No history of Chlamydia trachomatis, Mycoplasma genitalium, Neisseria gonorrhoeae, hepatitis B, or HIV
- For IVF subjects, minimum endometrial thickness of 7mm at sample collection
You will not qualify if you...
- Pregnant women
- Study subjects with endometrial cancer
- History of endometrial ablation
- Undiagnosed uterine bleeding
- Reproductive diseases affecting the endometrium such as fibroids or uterine polyps that distort the cavity
- Use of an intrauterine device (IUD)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants undergo biopsies and sample collection to assess ion channel and protein expression in the endometrium.
Visits scheduled according to menstrual cycles and IVF procedures as applicable
Duration - Up to 5 years
Participants are observed over time to track changes in endometrial expression levels across the menstrual cycle.
Periodic visits depending on individual menstrual cycle and study assessments
Trial Site Locations
Total: 3 locations
1
University of Georgia
Athens, Georgia, United States, 30602
Not Yet Recruiting
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
3
Rutgers University
Piscataway, New Jersey, United States, 08854
Active, Not Recruiting
Research Team
J
James Segars, MD
B
Bhuchitra Singh, MD, MPH, MS, MBA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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