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

NCT03157765 — Not applicable, Withdrawn, Brown Fertility

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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

Registry	NCT03157765
Status	Withdrawn - Change in research site
Phase	Not applicable
Study type	Interventional; randomized, single group, masking: none, treatment
Sponsor	Brown Fertility (Other)
Conditions	Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium
Interventions	endometrial biopsy (Procedure)
Dates	start 2017-06-01 (estimated), primary completion 2019-06-01 (estimated), completion 2019-06-01 (estimated), first posted 2017-05-17, last updated 2019-01-23

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
EMB intervention	Experimental	Procedure: endometrial biopsy	These patients receive and endometrial biopsy
Routine care	No intervention		These patient receive routine care

endometrial biopsy (Procedure): endometrial biopsy

+Outcome measures

Primary outcomes

Implantation rate [within 6 months after recruitment]: Sacs seen in early ultrasound divided by the number of embryos transferred
clinical pregnancy rate [within 6 months after recruitment]: Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers

Secondary outcomes

ongoing pregnancy rate [within 18 months of recruitment]: Viable or delivered pregnancies at conclusion of study divided by the number of embryo transfers
biochemical pregnancy rate [within 6 months after recruitment]: number of positive pregnancy test divided by number of embryo transfers
miscarriage rate [within 18 months after recruitment]: number of losses of clinical pregnancies divided by number of clinical pregnancies

+Eligibility

Sex: Female, ages: 18 Years to 49 Years, accepts healthy volunteers

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)

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