Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT06847685

Conditions

Endometriosis

Endometrioma

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Conditions

Endometriosis

Endometrioma

Study ID

NCT06847685

Start date

Feb 1, 2025

Status verified date

Mar, 2026

Completion date

Feb 1, 2030

Anticipated

Primary completion date

Feb 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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

Enrollment

140 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Expression levels of selected ion channels in human endometrium biopsies across the menstrual cycle. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Bhuchitra Singh, MD, MPH, MS, MBA

410-614-2000bsingh10@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Samya El Sayed, MD

selsaye4@jh.edu

Principal Investigator:

James Segars, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

  • Endometriosis
  • Endometrial biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-03-09.