Back to resultsTrial of Endometrial Scratch Prior to Frozen Embryo Transfer in Patients With Recurrent Implantation Failure
Primary Purpose
Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
endometrial biopsy
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium focused on measuring recurrent implantation failure, frozen embryo transfer, IVF, endometrial scratch, endometrial injury
Eligibility Criteria
Inclusion Criteria:
- At least two prior consecutive failed IVF or FET cycles with transfer of at least 3 high quality embryos and with last cycle a FET cycle
Exclusion Criteria:
- Alternate explanation for implantation failure (e.g., intrauterine pathology)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EMB intervention
Routine care
Arm Description
These patients receive and endometrial biopsy
These patient receive routine care
Outcomes
Primary Outcome Measures
Implantation rate
Sacs seen in early ultrasound divided by the number of embryos transferred
clinical pregnancy rate
Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers
Secondary Outcome Measures
ongoing pregnancy rate
Viable or delivered pregnancies at conclusion of study divided by the number of embryo transfers
biochemical pregnancy rate
number of positive pregnancy test divided by number of embryo transfers
miscarriage rate
number of losses of clinical pregnancies divided by number of clinical pregnancies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03157765
Brief Title
Trial of Endometrial Scratch Prior to Frozen Embryo Transfer in Patients With Recurrent Implantation Failure
Official Title
A Randomized Study on the Value of an Endometrial Scratch Prior to a Frozen Embryo Transfer Cycle in the Treatment of Recurrent Implantation Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Change in research site
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown Fertility
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Patients with a history of recurrent implantation failure who are planning a frozen embryo transfer (FET) are enrolled into the program. Patients are randomized to an endometrial biopsy prior to starting estrogen to prepare for the transfer of warmed vitrified embryos or to routine care.
Detailed Description
Patients who failed to achieve a clinical pregnancy after embryo transfer of at least three high quality embryos in at least two IVF or FET cycles and for whom their last failed cycle was a frozen embryo transfer are offered the opportunity to enroll in this study. All patients will follow our routine FET protocol.
On a randomized basis, selected patients will undergo an endometrial biopsy using a Pipelle disposable device in the week prior to starting estrogen to prepare her endometrium.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium
Keywords
recurrent implantation failure, frozen embryo transfer, IVF, endometrial scratch, endometrial injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMB intervention
Arm Type
Experimental
Arm Description
These patients receive and endometrial biopsy
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
These patient receive routine care
Intervention Type
Procedure
Intervention Name(s)
endometrial biopsy
Intervention Description
endometrial biopsy
Primary Outcome Measure Information:
Title
Implantation rate
Description
Sacs seen in early ultrasound divided by the number of embryos transferred
Time Frame
within 6 months after recruitment
Title
clinical pregnancy rate
Description
Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers
Time Frame
within 6 months after recruitment
Secondary Outcome Measure Information:
Title
ongoing pregnancy rate
Description
Viable or delivered pregnancies at conclusion of study divided by the number of embryo transfers
Time Frame
within 18 months of recruitment
Title
biochemical pregnancy rate
Description
number of positive pregnancy test divided by number of embryo transfers
Time Frame
within 6 months after recruitment
Title
miscarriage rate
Description
number of losses of clinical pregnancies divided by number of clinical pregnancies
Time Frame
within 18 months after recruitment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least two prior consecutive failed IVF or FET cycles with transfer of at least 3 high quality embryos and with last cycle a FET cycle
Exclusion Criteria:
Alternate explanation for implantation failure (e.g., intrauterine pathology)
12. IPD Sharing Statement
Learn more about this trial
Trial of Endometrial Scratch Prior to Frozen Embryo Transfer in Patients With Recurrent Implantation Failure
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