NCT06816381 · Reproductive Medicine Associates of New Jersey
Quantifying Uterine Elastography in Menstruating Women
(QUEST)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Exclusion criteria
- 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
- 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
- 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 C 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)
- Patient with no prior pregnancy history including miscarriages, terminations, ectopic pregnancies, preterm deliveries, or full-term deliveries (i.e gravity equals zero).
- Patient with diagnosis of primary infertility, with attempted conception for at least 12 months if younger than 35 years and attempted conception for at least 6 months if 35 years or older. Exclusion Criteria
- 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 three or more failed euploid embryo transfers
- Severe male factor infertility including severe oligozoospermia and cryptozoospermia
- 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.
Where
- Basking Ridge, New Jersey
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations