Measuring Uterine Elasticity in Women During Their Menstrual Cycle

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

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
• Enrollment: 40 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Reproductive Medicine Associates of New Jersey (other)
• Locations: 1 site (Basking Ridge, New Jersey)
• Trial ID: NCT06816381 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are menstruating women with normal menstrual cycles and no history of infertility or pregnancy.

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.

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 performed: While the use of elastography in reproductive health is emerging, this specific approach to quantifying uterine elasticity in menstruating women is relatively novel.

Eligibility 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 this trial is running

Basking Ridge, New Jersey

• RMA — Basking Ridge, New Jersey, United States (RECRUITING)

Study contacts

• Study coordinator: Caroline Zuckerman, BS, BSN, RN

Conditions: Infertility, Infertility Assisted Reproductive Technology