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

NCT ID: NCT03157765

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2019-06-30

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.

Conditions

Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EMB intervention

These patients receive and endometrial biopsy

Group Type: EXPERIMENTAL

endometrial biopsy

Intervention Type: PROCEDURE

endometrial biopsy

Routine care

These patient receive routine care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

endometrial biopsy

endometrial biopsy

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brown Fertility

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EMB for RIP/FET

Identifier Type: -

Identifier Source: org_study_id