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

Johns Hopkins University

Status: Enrolling

Conditions: Endometriosis; Endometrioma

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06847685

R01HD114750 (U.S. NIH Grant/Contract)

IRB00423161

Details and patient eligibility

About

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

Enrollment: 140 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

140 participants in 2 patient groups

Women between the ages of 18 and 45 years with or without endometriosis

Description:

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

Description:

20 women with endometrial lumen fluid and 20 women without endometrial lumen fluid