Quantifying Uterine Elastography in Menstruating Women
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorReproductive Medicine Associates of New Jersey
About this trial
This study is aiming to characterize the elasticity of the female reproductive tract including the uterus, cervix and ovary using shear wave elastography at different times during the menstrual cycle and define the standard reference range of normal uterine and ovarian elasticity. By doing so, the potential of using shear wave elastography to diagnose and predict outcomes for patients seeking fertility treatment might be established.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with normal menstrual cycles lasting 28-34 days
Patients with normal uterine anatomy
Patients with no prior pregnancy history including miscarriages, terminations, ectopic pregnancies, preterm deliveries, or full-term deliveries
Patient who have no known infertility (i.e. women who have not tried to conceive)
Disqualifiers
BMI ≥ 35
Current use of intrauterine devices (IUDs), hormonal implants, or hormonal birth control medications. Participants on hormonal birth control interested in study participation may be included following one month of discontinuation of hormonal medication.
History of uterine surgery (i.e hysteroscopy, dilation and curettage, myomectomy)
History of ovarian surgery (i.e ovarian cystectomy, oophorectomy, removal of -endometrioma)
Trial population
Nulliparous women with no known infertility, gravid women with no known infertility and primary infertile women without uterine factor infertility
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Shear wave elastography measurements
DeviceShear wave elastography measurements in kilopascals via ultrasound
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: Nulliparous Women with No Known infertility0 interventions
Group B: Gravid Women with No Known infertility0 interventions
Group C: Primary Infertile Women Without Uterine Factor Infertility1 intervention
Trial outcomes
Primary outcomes
1
Shear wave elastography parameters
shear wave elastography measurements in kilopascals
Time frame
3-4 months from enrollmentSponsors and contacts
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Source ClinicalTrials.gov