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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2030-02-01

Brief Summary

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

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Detailed Description

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Conditions

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Endometriosis Endometrioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

50 women with endometriosis (cases) and 50 without endometriosis (controls)

No interventions assigned to this group

Women between the ages of 18 and 45 years with or without endometrial cavity fluid undergoing IVF

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

No interventions assigned to this group

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes