EndometriosisNCT06847685
Mechanisms of Uterine Fluid Absorption During Early Pregnancy ( ELF Study)
An observational study of Endometriosis and Endometrioma, run by Johns Hopkins University at 3 sites in United States.
Trial summary
The researchers are evaluating mechanisms of uterine fluid absorption during early pregnancy Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Endometrioma
- How many people
- 140 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2025to 1 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women between the ages of 18-45 with or without endometriosis.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 2 recruiting
- Not yet recruiting
University of Georgia
Athens, Georgia, 30602
Xiaoqin Ye, MD, PhD, ye@uga.edu
Xiaoqin Ye, MD, PhD
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Samya El Sayed, MD, selsaye4@jh.edu
James Segars, MD
- Active, not recruiting
Rutgers University
Piscataway, New Jersey, 08854
About this study
Official title: Mechanisms of Uterine Fluid Absorption During Early Pregnancy
The researchers are evaluating mechanisms of uterine fluid absorption during early pregnancy
- Conditions
- Endometriosis, Endometrioma
- Keywords
- Endometriosis, Endometrial biopsy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Feb 2025
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- James Segars, MD, Study chair, Johns Hopkins UniversityBhuchitra Singh, MD, MPH, MS, MBA, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847685
- Sponsor's protocol ID
- IRB00423161
- Other IDs
- R01HD114750
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Uterine Fluid Absorption During Early Pregnancy
- ClinicalTrials.gov ID
- NCT06847685
- Acronym / sponsor ID
- IRB00423161
- Conditions
- Endometriosis, Endometrioma
- Keywords
- Endometriosis, Endometrial biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are evaluating mechanisms of uterine fluid absorption during early pregnancy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women between the ages of 18-45 with or without endometriosis.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expression levels of selected ion channels in human endometrium biopsies across the menstrual cycle.
Time frame: 5 years
Immunolocalization of ion channel levels ENaCα, SLC5A1 and SLC5A3 in endometrial tissues.
1 secondary outcome
Compare relative protein expression of ENaCα, SLC5A1 and SLC5A3 by immunohistochemistry
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Segars, MD study chair
Johns Hopkins University
Bhuchitra Singh, MD, MPH, MS, MBA study director
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Endometrioma, run by Johns Hopkins University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Segars, MD (410-614-2000, jsegars2@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of selected ion channels in human endometrium biopsies across the menstrual cycle. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.