Can ultrasound stiffness tests predict fertility?
NCT ID NCT06816381
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study uses a special ultrasound technique called shear wave elastography to measure how stiff the uterus, cervix, and ovaries are in women with and without fertility problems. Researchers will track changes across the menstrual cycle in 40 women to establish normal ranges. The goal is to see if tissue stiffness can help diagnose infertility or predict treatment outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors use ultrasound to better diagnose fertility issues or predict IVF success.
- What could go wrong
- This is a very small pilot study (40 people) that only measures tissue stiffness—it does not test any treatment. The findings may not lead to a practical diagnostic tool.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Nulliparous women with no known infertility, gravid women with no known infertility and primary infertile women without uterine factor infertility
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Group A 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: * 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 * 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 * 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 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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
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The places running it
1 site. The list below names each one and where it is.
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The official record
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A doctor treating you
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Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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Contact
Email: •••••@•••••
Locations
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RMA
RECRUITINGBasking Ridge, New Jersey, 07920, United States
Contact Email: •••••@•••••
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