Phase
Condition
Infertility
Treatment
Shear wave elastography measurements
Clinical Study ID
Ages 18-45 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
BMI ≥ 35
Current use of intrauterine devices (IUDs), hormonal implants, or hormonal birthcontrol medications. Participants on hormonal birth control interested in studyparticipation may be included following one month of discontinuation of hormonalmedication.
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 ultrasoundevidence 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 SonographicAssessment 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 onscreening visit ultrasound)
Patients with at least one prior full-term vaginal delivery with time to conceptionless than one year without the use of assisted reproductive technology.
Exclusion Criteria
BMI ≥ 35
Current use of intrauterine devices (IUDs), hormonal implants, or hormonal birthcontrol medications. Participants on hormonal birth control interested in studyparticipation may be included following one month of discontinuation of hormonalmedication.
History of cesarean section
Patient who have no known secondary infertility (i.e. women who have not tried toconceive)
Diagnosis of secondary infertility (i.e women who have attempted pregnancy for 12months without success)
History of uterine surgery (i.e hysteroscopy, dilation and curettage, myomectomy)
History of ovarian surgery (i.e ovarian cystectomy, oophorectomy, removal ofendometrioma)
History of surgically-confirmed or clinically suspected endometriosis or ultrasoundevidence 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 SonographicAssessment 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 onscreening visit ultrasound)
Patient with no prior pregnancy history including miscarriages, terminations,ectopic pregnancies, preterm deliveries, or full-term deliveries (i.e gravity equalszero).
Patient with diagnosis of primary infertility, with attempted conception for atleast 12 months if younger than 35 years and attempted conception for at least 6months if 35 years or older.
Exclusion Criteria
BMI ≥ 35
Current use of intrauterine devices (IUDs), hormonal implants, or hormonal birthcontrol medications. Participants on hormonal birth control interested in studyparticipation may be included following one month of discontinuation of hormonalmedication.
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 ofendometrioma)
History of surgically-confirmed or clinically suspected endometriosis or ultrasoundevidence 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 SonographicAssessment 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
Connect with a study center
RMA
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
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