Measuring Uterine Elasticity in Women During Their Menstrual Cycle
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
Run by Reproductive Medicine Associates of New Jersey · NCT06816381 · Data updated 2026-11-12
This study is testing how stretchy the uterus and ovaries are at different times during the menstrual cycle to see if this information can help women with fertility treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Reproductive Medicine Associates of New Jersey Academic / other |
| Locations | 1 site (Basking Ridge, New Jersey) |
| Status | Recruiting |
| Started | February 6, 2025 |
| Main results expected | August 2027 |
| Study ends | December 2027 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT06816381 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are menstruating women with normal menstrual cycles and no history of infertility or pregnancy.
✕Probably not a fit
Patients with a BMI of 35 or higher, those using hormonal birth control, or with a history of uterine or ovarian surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to characterize the elasticity of the female reproductive tract, including the uterus, cervix, and ovary, using shear wave elastography at various points during the menstrual cycle. By establishing a standard reference range for normal uterine and ovarian elasticity, the study seeks to explore the potential of this technology in diagnosing and predicting outcomes for women undergoing fertility treatments. The approach involves non-invasive measurements that could provide valuable insights into reproductive health.
Why it matters
Potential benefit: If successful, this study could improve the diagnosis and treatment outcomes for women seeking fertility assistance.
How similar studies have gone: While the use of elastography in reproductive health is emerging, this specific approach to quantifying uterine elasticity in menstruating women is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Rma
Basking Ridge, New Jersey, United States Recruiting
Study contacts
- Study coordinator: Caroline Zuckerman, BS, BSN, RN
- Email: clinicalresearchteam@ivirma.com
- Phone: 9736562841
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.