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Recruiting

NCT Number: NCT06847685

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

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

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Georgia, Athens, Georgia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Expression levels of selected ion channels in human endometrium biopsies across the menstrual cycle.

    Time frame: 5 years

    Immunolocalization of ion channel levels ENaCα, SLC5A1 and SLC5A3 in endometrial tissues.

Secondary outcomes

  1. Compare relative protein expression of ENaCα, SLC5A1 and SLC5A3 by immunohistochemistry

    Time frame: 5 years

    Compare relative protein expression of ENaCα, SLC5A1 and SLC5A3 by immunohistochemistry in the human endometrial biopsies from women with or without endometriosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Bhuchitra Singh, MD, MPH, MS, MBA

CONTACT

[email protected]

410-614-2000

James Segars, MD

CONTACT

[email protected]

410-614-2000

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

Mechanisms of Uterine Fluid Absorption During Early Pregnancy

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Feb 26, 2025
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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