Menu
Recruiting NCT06847685

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

Observational Endometriosis Endometrioma

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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗