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NCT Number: NCT06816381

Quantifying Uterine Elastography in Menstruating Women

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

RMA

Basking Ridge, New Jersey, 07920, United States

Location status: Recruiting

Location contact

Christine Whitehead, MS, BSN, RN

CONTACT

[email protected]

9736562841

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shear wave elastography measurements

Device

Shear wave elastography measurements in kilopascals via ultrasound

Primary outcomes

  1. Shear wave elastography parameters

    Time frame: 3-4 months from enrollment

    shear wave elastography measurements in kilopascals

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Zuckerman, BS, BSN, RN

CONTACT

[email protected]

9736562841

Christine Whitehead, MS, BSN, RN

CONTACT

[email protected]

9736562841

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Registry information

Official study title

Characterizing Uterine and Ovarian Tissue Stiffness Via Shear Wave Elastography in Non-Infertile, Fertile, and Infertile Women With Normal Anatomy Across the Menstrual Cycle: A Pilot Study

Acronym: QUEST

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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