Actively Recruiting

Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT06816381

Quantifying Uterine Elastography in Menstruating Women

Led by Reproductive Medicine Associates of New Jersey · Updated on 2025-02-13

40

Participants Needed

1

Research Sites

94 weeks

Total Duration

On this page

AI-Summary

What this Trial 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. By doing so, the potential of using shear wave elastography to diagnose and predict outcomes for patients seeking fertility treatment might be established.

CONDITIONS

Official Title

Quantifying Uterine Elastography in Menstruating Women

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

Group A

  • 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)
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

RMA

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

Loading map...

Research Team

C

Caroline Zuckerman, BS, BSN, RN

CONTACT

C

Christine Whitehead, MS, BSN, RN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here