Trial Outcomes & Findings for SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF (NCT NCT04415489)
NCT ID: NCT04415489
Last Updated: 2021-05-19
Results Overview
Survey with Likert scale administered to record patients overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Immediately following imaging modality (less than 30 minutes)
Results posted on
2021-05-19
Participant Flow
Participant milestones
| Measure |
Office Hysteroscopy
Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.
|
Saline Infusion Sonography (SIS)
This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BMI data were missing for 5 participants in the SIS arm.
Baseline characteristics by cohort
| Measure |
Office Hysteroscopy
n=50 Participants
Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.
|
Saline Infusion Sonography (SIS)
n=50 Participants
This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 4.6 • n=50 Participants
|
34.7 years
STANDARD_DEVIATION 4.9 • n=50 Participants
|
34.3 years
STANDARD_DEVIATION 4.8 • n=100 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
100 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
3 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
4 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
5 Participants
n=50 Participants
|
6 Participants
n=50 Participants
|
11 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
42 Participants
n=50 Participants
|
39 Participants
n=50 Participants
|
81 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
0 Participants
n=50 Participants
|
4 Participants
n=50 Participants
|
4 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
100 Participants
n=100 Participants
|
|
Body Mass Index (BMI)
|
26.2 Kg/m^2
STANDARD_DEVIATION 6.4 • n=50 Participants • BMI data were missing for 5 participants in the SIS arm.
|
27.7 Kg/m^2
STANDARD_DEVIATION 6.4 • n=45 Participants • BMI data were missing for 5 participants in the SIS arm.
|
26.9 Kg/m^2
STANDARD_DEVIATION 6.4 • n=95 Participants • BMI data were missing for 5 participants in the SIS arm.
|
|
Infertility Diagnosis
Diminished ovarian reserve
|
3 Participants
n=50 Participants
|
7 Participants
n=50 Participants
|
10 Participants
n=100 Participants
|
|
Infertility Diagnosis
Endometriosis
|
3 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
4 Participants
n=100 Participants
|
|
Infertility Diagnosis
Ovulatory dysfunction
|
10 Participants
n=50 Participants
|
7 Participants
n=50 Participants
|
17 Participants
n=100 Participants
|
|
Infertility Diagnosis
Male factor
|
17 Participants
n=50 Participants
|
10 Participants
n=50 Participants
|
27 Participants
n=100 Participants
|
|
Infertility Diagnosis
Tubal factor
|
1 Participants
n=50 Participants
|
4 Participants
n=50 Participants
|
5 Participants
n=100 Participants
|
|
Infertility Diagnosis
Unexplained
|
10 Participants
n=50 Participants
|
13 Participants
n=50 Participants
|
23 Participants
n=100 Participants
|
|
Infertility Diagnosis
Other
|
6 Participants
n=50 Participants
|
8 Participants
n=50 Participants
|
14 Participants
n=100 Participants
|
|
Prior Uterine Surgery
Dilation and curettage
|
4 Participants
n=50 Participants
|
9 Participants
n=50 Participants
|
13 Participants
n=100 Participants
|
|
Prior Uterine Surgery
Myomectomy
|
4 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
6 Participants
n=100 Participants
|
|
Prior Uterine Surgery
Polypectomy
|
0 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
2 Participants
n=100 Participants
|
|
Prior Uterine Surgery
Lysis of adhesions
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Prior Uterine Surgery
Caesarean section
|
7 Participants
n=50 Participants
|
7 Participants
n=50 Participants
|
14 Participants
n=100 Participants
|
|
Prior Uterine Surgery
Other
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Prior Uterine Surgery
None
|
34 Participants
n=50 Participants
|
30 Participants
n=50 Participants
|
64 Participants
n=100 Participants
|
|
History of Uterine Pathology
History of uterine pathology
|
2 Participants
n=50 Participants
|
4 Participants
n=50 Participants
|
6 Participants
n=100 Participants
|
|
History of Uterine Pathology
No history of uterine pathology
|
48 Participants
n=50 Participants
|
46 Participants
n=50 Participants
|
94 Participants
n=100 Participants
|
|
Vaginal Delivery History
Prior Vaginal Delivery
|
9 Participants
n=50 Participants
|
11 Participants
n=50 Participants
|
20 Participants
n=100 Participants
|
|
Vaginal Delivery History
No prior Vaginal Delivery
|
41 Participants
n=50 Participants
|
39 Participants
n=50 Participants
|
80 Participants
n=100 Participants
|
|
Number of Participants with Prior Cervical Surgery
|
1 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Immediately following imaging modality (less than 30 minutes)Survey with Likert scale administered to record patients overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).
Outcome measures
| Measure |
Office Hysteroscopy
n=50 Participants
Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.
|
Saline Infusion Sonography (SIS)
n=50 Participants
This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
|
|---|---|---|
|
Patient Satisfaction
|
4.92 units on a scale
Standard Deviation 0.34
|
4.84 units on a scale
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: Immediately following imaging modality (less than 30 minutes)Survey administered to record patients pain scores during their procedure. Score range is 1-10, with one being minimal pain (better) and 10 being the worst pain ever experienced (worse).
Outcome measures
| Measure |
Office Hysteroscopy
n=50 Participants
Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.
|
Saline Infusion Sonography (SIS)
n=50 Participants
This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
|
|---|---|---|
|
Pain Scores
|
3.38 units on a scale
Standard Deviation 1.85
|
2.44 units on a scale
Standard Deviation 1.64
|
PRIMARY outcome
Timeframe: Immediately following imaging modality (less than 30 minutes)Survey with Likert scale administered to record providers overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).
Outcome measures
| Measure |
Office Hysteroscopy
n=50 Surveys analyzed
Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.
|
Saline Infusion Sonography (SIS)
n=50 Surveys analyzed
This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
|
|---|---|---|
|
Provider Satisfaction
|
4.76 units on a scale
Standard Deviation 0.69
|
4.56 units on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: During the allotted procedure onlyLength of time to complete procedure in minutes
Outcome measures
| Measure |
Office Hysteroscopy
n=50 Participants
Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.
|
Saline Infusion Sonography (SIS)
n=50 Participants
This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
|
|---|---|---|
|
Time to Complete
|
4.61 minutes
Standard Deviation 2.42
|
3.98 minutes
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: Through study completion, up to 1 yearNumber of patients requiring a secondary procedure, either for management of pathology or inability to complete initial procedure.
Outcome measures
| Measure |
Office Hysteroscopy
n=50 Participants
Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.
|
Saline Infusion Sonography (SIS)
n=50 Participants
This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
|
|---|---|---|
|
Number of Patients Requiring Secondary Procedure
|
1 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 1 yearPopulation: Number of Patients requiring secondary procedure was used instead to represent potential for treatment delay. This measure was abandoned and no data was collected, based on the following factors making it less reliable: (1) variability of ability to add a second procedure case on the same day (for patient and/or provider), and (2) presence of other uncontrollable factors contributing to fertility treatment delay
Number of days to achieve planned fertility treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 1 yearPopulation: Reported for those participants with abnormal finding during SIS procedure
Number of Participants with SIS Findings, Validated by Subsequent Hysteroscopy
Outcome measures
| Measure |
Office Hysteroscopy
n=11 Participants
Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.
|
Saline Infusion Sonography (SIS)
This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
|
|---|---|---|
|
Positive Predictive Value of SIS
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: During the allotted procedure onlyPopulation: Participants with abnormal finding during office hysteroscopy
Number of participants with pathology on hysteroscopy successfully managed within same procedure
Outcome measures
| Measure |
Office Hysteroscopy
n=17 Participants
Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.
|
Saline Infusion Sonography (SIS)
This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
|
|---|---|---|
|
Ability to Manage Pathology With Office Hysteroscopy
|
16 Participants
|
—
|
POST_HOC outcome
Timeframe: During the allotted procedure onlyDescriptive characterization of pathology identified for participants, if any, during procedure.
Outcome measures
| Measure |
Office Hysteroscopy
n=50 Participants
Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.
|
Saline Infusion Sonography (SIS)
n=50 Participants
This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
|
|---|---|---|
|
Number of Participants With Pathology Found
Polyps
|
10 Participants
|
7 Participants
|
|
Number of Participants With Pathology Found
Myoma
|
0 Participants
|
1 Participants
|
|
Number of Participants With Pathology Found
Adhesions
|
2 Participants
|
2 Participants
|
|
Number of Participants With Pathology Found
Retained product
|
5 Participants
|
1 Participants
|
|
Number of Participants With Pathology Found
Uterine anomaly
|
2 Participants
|
0 Participants
|
|
Number of Participants With Pathology Found
Inconclusive
|
0 Participants
|
1 Participants
|
|
Number of Participants With Pathology Found
None
|
31 Participants
|
38 Participants
|
Adverse Events
Office Hysteroscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Infusion Sonography (SIS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sarah Moustafa, MD
University of North Carolina at Chapel Hill
Phone: 919-908-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place