Quantifying Uterine Elastography in Menstruating Women (QUEST)

Reproductive Medicine Associates of New Jersey

Status: Enrolling

Conditions: Infertility Assisted Reproductive Technology; Infertility (IVF Patients)

Treatments: Device: Shear wave elastography measurements

Study type: Observational

Funder types: Other

Identifiers

NCT06816381

2401-BRG-003-FB

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

40 participants in 3 patient groups

Nulliparous Women with No Known infertility

Description:

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)

Treatment:

Device: Shear wave elastography measurements

Gravid Women with No Known infertility

Description:

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

Treatment:

Device: Shear wave elastography measurements

Primary Infertile Women Without Uterine Factor Infertility

Description:

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) that has been diagnosed with primary infertility

Treatment:

Device: Shear wave elastography measurements