Recruiting NCT06847685
Mechanisms of Uterine Fluid Absorption During Early Pregnancy ( ELF Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Endometriosis, Endometrioma. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mechanisms of Uterine Fluid Absorption During Early Pregnancy
Overview
The researchers are evaluating mechanisms of uterine fluid absorption during early pregnancy
Primary outcome measures
- Expression levels of selected ion channels in human endometrium biopsies across the menstrual cycle. [Time frame: 5 years]
Secondary outcome measures (1)
- Compare relative protein expression of ENaCα, SLC5A1 and SLC5A3 by immunohistochemistry [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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.
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- University of Georgia — Athens
- Johns Hopkins Hospital — Baltimore
- Rutgers University — Piscataway
Identifiers
NCT: NCT06847685 · IRB00423161 · R01HD114750