RECRUITING

Quantifying Uterine Elastography in Menstruating Women

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2025-02-06
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06816381

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with normal menstrual cycles lasting 28-34 days
  2. * Patients with normal uterine anatomy
  3. * Patients with no prior pregnancy history including miscarriages, terminations, ectopic pregnancies, preterm deliveries, or full-term deliveries
  4. * Patient who have no known infertility (i.e. women who have not tried to conceive)
  1. * BMI ≥ 35
  2. * 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.
  3. * History of uterine surgery (i.e hysteroscopy, dilation and curettage, myomectomy)
  4. * History of ovarian surgery (i.e ovarian cystectomy, oophorectomy, removal of -endometrioma)
  5. * History of surgically-confirmed or clinically suspected endometriosis or ultrasound evidence of endometriosis (i.e endometrioma)
  6. * Currently present or surgically corrected uterine anomalies
  7. * Ultrasound evidence of or history of communicating hydrosalpinx
  8. * Ultrasound evidence of or history of leiomyomas
  9. * Ultrasound evidence of adenomyosis based on the Morphological Uterus Sonographic Assessment criteria (MUSA) (19)
  10. * Ultrasound evidence of ovarian pathology including mature teratoma/dermoid cyst, persistent functional cysts larger than 2 cm, or ovarian cancer.

Contacts and Locations

Study Contact

Caroline Zuckerman, BS, BSN, RN
CONTACT
9736562841
clinicalresearchteam@ivirma.com
Christine Whitehead, MS, BSN, RN
CONTACT
9736562841
clinicalresearchteam@ivirma.com

Study Locations (Sites)

RMA
Basking Ridge, New Jersey, 07920
United States

Collaborators and Investigators

Sponsor: Reproductive Medicine Associates of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-06
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-02-06
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Infertility (IVF Patients)
  • Infertility Assisted Reproductive Technology