Quantifying Uterine Elastography in Menstruating Women
Recruiting now
Conditions studied: Infertility (IVF Patients), Infertility Assisted Reproductive Technology
In brief
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.
Key facts
- Study ID
- NCT06816381
- Run by
- Reproductive Medicine Associates of New Jersey
- People needed
- 40
- Starts
- 2025-02-06
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
- History of surgically-confirmed or clinically suspected endometriosis or ultrasound evidence of endometriosis (i.e endometrioma)
- Currently present or surgically corrected uterine anomalies
- Ultrasound evidence of or history of communicating hydrosalpinx
- Ultrasound evidence of or history of leiomyomas
- Ultrasound evidence of adenomyosis based on the Morphological Uterus Sonographic Assessment criteria (MUSA) (19)
- Ultrasound evidence of ovarian pathology including mature teratoma/dermoid cyst, persistent functional cysts larger than 2 cm, or ovarian cancer.
- Group B
- Inclusion Criteria:
- Patients with normal menstrual cycles lasting 28 days to 34 days.
- Patients with normal uterine and ovarian anatomy (absence of gross pathology on screening visit ultrasound)
- Patients with at least one prior full-term vaginal delivery with time to conception less than one year without the use of assisted reproductive technology.
- Exclusion Criteria
- 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 cesarean section
- Patient who have no known secondary infertility (i.e. women who have not tried to conceive)
- Diagnosis of secondary infertility (i.e women who have attempted pregnancy for 12 months without success)
- History of uterine surgery (i.e hysteroscopy, dilation and curettage, myomectomy)
- History of ovarian surgery (i.e ovarian cystectomy, oophorectomy, removal of endometrioma)
- History of surgically-confirmed or clinically suspected endometriosis or ultrasound evidence of endometriosis (i.e endometrioma)
- Currently present or surgically corrected uterine anomalies
Where it is running
- RMA — Basking Ridge, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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