Recruiting

Uterine ElastographyQuantifying Uterine Elastography in Menstruating Women

Sponsor:

Reproductive Medicine Associates of New Jersey

Code:

NCT06816381

Conditions

Infertility (IVF Patients)

Infertility Assisted Reproductive Technology

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Shear wave elastography measurements

Study Details

Brief summary:

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

Infertility (IVF Patients)

Infertility Assisted Reproductive Technology

Study ID

NCT06816381

Start date

Feb 6, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Nulliparous Women with No Known infertility

Female patients with normal menstrual cycles, normal ovarian and uterine anatomy and with no known prior pregnancy (including miscarriages, terminations, ectopic pregnancies, preterm and full term deliveries)

Gravid Women with No Known infertility

Female patients with normal menstrual cycles, normal ovarian and uterine anatomy with at least one prior full term vaginal delivery with no known infertility

Primary Infertile Women Without Uterine Factor Infertility

Interventions

Shear wave elastography measurements

Shear wave elastography measurements in kilopascals via ultrasound

Primary outcome measure

Shear wave elastography parameters [ Time Frame: 3-4 months from enrollment ]

Central Contacts and Locations

Central contacts

Caroline Zuckerman, BS, BSN, RN

9736562841 clinicalresearchteam@ivirma.com

Christine Whitehead, MS, BSN, RN

9736562841 clinicalresearchteam@ivirma.com

Locations

RMA

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Christine Whitehead, MS, BSN, RN

9736562841 clinicalresearchteam@ivirma.com

More Information

Sponsor

Reproductive Medicine Associates of New Jersey

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Reproductive Medicine Associates of New Jersey on 2026-06-03.