Trial of Endometrial Scratch Prior to Frozen Embryo Transfer in Patients With Recurrent Implantation Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Study on the Value of an Endometrial Scratch Prior to a Frozen Embryo Transfer Cycle in the Treatment of Recurrent Implantation Failure

Conditions
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Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium

Intervention / Treatment
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* Procedure: endometrial biopsy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMB intervention<br>These patients receive and endometrial biopsy | Procedure: endometrial biopsy<br>* endometrial biopsy<br>|
| No Intervention: Routine care<br>These patient receive routine care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | Sacs seen in early ultrasound divided by the number of embryos transferred | within 6 months after recruitment | 
| clinical pregnancy rate | Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers | within 6 months after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy rate | Viable or delivered pregnancies at conclusion of study divided by the number of embryo transfers | within 18 months of recruitment | 
| biochemical pregnancy rate | number of positive pregnancy test divided by number of embryo transfers | within 6 months after recruitment | 
| miscarriage rate | number of losses of clinical pregnancies divided by number of clinical pregnancies | within 18 months after recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, recurrent implantation failure, frozen embryo transfer, endometrial scratch, endometrial injury