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Can ultrasound stiffness tests predict fertility?

NCT ID NCT06816381

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The study's own enquiry address

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  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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    Open the record ↗

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • RMA

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

    Contact Email: •••••@•••••

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