Trial Outcomes & Findings for Comparing Two Types of Endometrial Activation Prior to Embryo Transfer (NCT NCT04363879)
NCT ID: NCT04363879
Last Updated: 2022-10-20
Results Overview
Number (count) of births per number of subjects undergoing embryo transfer
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
195 participants
Primary outcome timeframe
Collected up to 1 year after the last embryo transfer
Results posted on
2022-10-20
Participant Flow
Participant milestones
| Measure |
Endometrial Scratch With Pipelle Curette
For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
|
Endometrial Scratch With Shepard Catheter
For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.
Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
92
|
|
Overall Study
COMPLETED
|
78
|
92
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Endometrial Scratch With Pipelle Curette
n=78 Participants
For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
|
Endometrial Scratch With Shepard Catheter
n=92 Participants
For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.
Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.8 Years
STANDARD_DEVIATION 4.6 • n=78 Participants
|
34.2 Years
STANDARD_DEVIATION 3.9 • n=92 Participants
|
34.0 Years
STANDARD_DEVIATION 4.2 • n=170 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=78 Participants
|
92 Participants
n=92 Participants
|
170 Participants
n=170 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=78 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=170 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=78 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=170 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=78 Participants
|
75 Participants
n=92 Participants
|
91 Participants
n=170 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
62 Participants
n=78 Participants
|
17 Participants
n=92 Participants
|
79 Participants
n=170 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
78 participants
n=78 Participants
|
92 participants
n=92 Participants
|
170 participants
n=170 Participants
|
PRIMARY outcome
Timeframe: Collected up to 1 year after the last embryo transferNumber (count) of births per number of subjects undergoing embryo transfer
Outcome measures
| Measure |
Endometrial Scratch With Pipelle Curette
n=78 Participants
For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
|
Endometrial Scratch With Shepard Catheter
n=92 Participants
For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.
Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.
|
|---|---|---|
|
Number of Participants With Live Births Per Transfers Performed
|
37 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Immediately following endometrial scratchPain assessed by Visual analog scale (Numeric rating scale, units from 1-10 with 1 being no pain and 10 being maximum pain)
Outcome measures
| Measure |
Endometrial Scratch With Pipelle Curette
n=78 Participants
For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
|
Endometrial Scratch With Shepard Catheter
n=92 Participants
For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.
Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.
|
|---|---|---|
|
Pain Quantifcation After Endometrial Scratch
|
3.9 score on a scale
Standard Deviation 2.2
|
3.0 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Collected up to 1 year after the last embryo transferOutcome measures
| Measure |
Endometrial Scratch With Pipelle Curette
n=78 Participants
For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
|
Endometrial Scratch With Shepard Catheter
n=92 Participants
For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.
Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.
|
|---|---|---|
|
Number (Count) of Positive Pregnancy Tests Per Number of Subjects Undergoing Embryo Transfer
|
56 positive pregnancy tests
|
62 positive pregnancy tests
|
SECONDARY outcome
Timeframe: Collected up to 1 year after the last embryo transferOutcome measures
| Measure |
Endometrial Scratch With Pipelle Curette
n=78 Participants
For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
|
Endometrial Scratch With Shepard Catheter
n=92 Participants
For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.
Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.
|
|---|---|---|
|
Number (Count) of Pregnancies Per Number of Patients Undergoing Embryo Transfer
|
44 number of pregnancies
|
55 number of pregnancies
|
Adverse Events
Endometrial Scratch With Pipelle Curette
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Endometrial Scratch With Shepard Catheter
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
Dr. Brad Hurst, Director of Assisted Reproduction Program
AtriumHealth
Phone: 7043553153
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place