Clinical trial NCT06816381: Quantifying Uterine Elastography in Menstruating Women
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility (IVF Patients)
Infertility Assisted Reproductive Technology
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nulliparous women with no known infertility, gravid women with no known infertility and primary infertile women without uterine factor infertility

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.


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.

Primary outcomes:
measure: Shear wave elastography parameters
timeFrame: 3-4 months from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: RMA
state: New Jersey
Study officials:
References:
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