Understanding how the uterus absorbs fluid during early pregnancy

Mechanisms of Uterine Fluid Absorption During Early Pregnancy

This study is trying to understand how the uterus absorbs fluid during early pregnancy in women, both with and without endometriosis, to learn more about the process.

Quick facts

• Study type: Observational
• Enrollment: 140 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 3 sites (Athens, Georgia and 2 other locations)
• Trial ID: NCT06847685 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the mechanisms of uterine fluid absorption during early pregnancy, focusing on women with and without endometriosis. It includes healthy women aged 18 to 45, as well as those diagnosed with endometriosis or infertility. The study will analyze various factors, including menstrual cycle regularity and endometrial thickness, to understand the physiological processes involved. Participants will be recruited from multiple locations, including Johns Hopkins Hospital and Rutgers University.

Who should consider this trial

Good fit: Ideal candidates include healthy women aged 18 to 45, those diagnosed with endometriosis or infertility, and those with regular menstrual cycles.

Not a fit: Patients who are currently pregnant or have a history of endometrial cancer or ablation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of uterine function and improve treatment strategies for women with endometriosis and infertility.

How similar studies have performed: While this study explores a specific mechanism in early pregnancy, similar studies have shown promise in understanding reproductive health, making this approach both relevant and potentially impactful.

Eligibility criteria

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).

Where this trial is running

Athens, Georgia and 2 other locations

• University of Georgia — Athens, Georgia, United States (Not_yet_recruiting)
• Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
• Rutgers University — Piscataway, New Jersey, United States (Active_not_recruiting)

Study contacts

• Study coordinator: James Segars, MD

Conditions Endometriosis; Endometrioma; Endometrial biopsy