Quantifying Uterine Elastography in Menstruating Women

Last updated: February 11, 2025
Sponsor: Reproductive Medicine Associates of New Jersey
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

Shear wave elastography measurements

Clinical Study ID

NCT06816381
2401-BRG-003-FB
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Inclusion

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

Exclusion Criteria:

  • BMI ≥ 35

  • Current use of intrauterine devices (IUDs), hormonal implants, or hormonal birthcontrol medications. Participants on hormonal birth control interested in studyparticipation may be included following one month of discontinuation of hormonalmedication.

  • 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 ultrasoundevidence 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 SonographicAssessment 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 onscreening visit ultrasound)

  • Patients with at least one prior full-term vaginal delivery with time to conceptionless than one year without the use of assisted reproductive technology.

Exclusion Criteria

  • BMI ≥ 35

  • Current use of intrauterine devices (IUDs), hormonal implants, or hormonal birthcontrol medications. Participants on hormonal birth control interested in studyparticipation may be included following one month of discontinuation of hormonalmedication.

  • History of cesarean section

  • Patient who have no known secondary infertility (i.e. women who have not tried toconceive)

  • Diagnosis of secondary infertility (i.e women who have attempted pregnancy for 12months without success)

  • History of uterine surgery (i.e hysteroscopy, dilation and curettage, myomectomy)

  • History of ovarian surgery (i.e ovarian cystectomy, oophorectomy, removal ofendometrioma)

  • History of surgically-confirmed or clinically suspected endometriosis or ultrasoundevidence 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 SonographicAssessment 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 onscreening visit ultrasound)

  • Patient with no prior pregnancy history including miscarriages, terminations,ectopic pregnancies, preterm deliveries, or full-term deliveries (i.e gravity equalszero).

  • Patient with diagnosis of primary infertility, with attempted conception for atleast 12 months if younger than 35 years and attempted conception for at least 6months if 35 years or older.

Exclusion Criteria

  • BMI ≥ 35

  • Current use of intrauterine devices (IUDs), hormonal implants, or hormonal birthcontrol medications. Participants on hormonal birth control interested in studyparticipation may be included following one month of discontinuation of hormonalmedication.

  • 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 ofendometrioma)

  • History of surgically-confirmed or clinically suspected endometriosis or ultrasoundevidence 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 SonographicAssessment criteria (MUSA) (19)

  • Ultrasound evidence of ovarian pathology including mature teratoma/dermoid cyst,persistent functional cysts larger than 2 cm, or ovarian cancer.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Shear wave elastography measurements
Phase:
Study Start date:
February 06, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • RMA

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

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