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

Launched by JOHNS HOPKINS UNIVERSITY · Feb 21, 2025

Keywords

ClinConnect Summary

The ELF Study is a clinical trial designed to understand how the uterus absorbs fluid during early pregnancy, particularly in women with conditions like endometriosis or endometriomas. Researchers are looking for healthy women between 18 and 45 years old, including those diagnosed with endometriosis or infertility and those without these conditions. To participate, women should have regular menstrual cycles and a body mass index (BMI) between 18 and 40. Importantly, participants must not be pregnant or have certain reproductive health issues.

If you qualify and decide to join the study, you will help researchers learn more about the early stages of pregnancy and how the uterus functions. Your involvement will include providing consent for the study procedures and sharing some health information. This research aims to improve our understanding of uterine health, which could benefit women facing fertility challenges in the future.

Gender

FEMALE

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).