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

Not Applicable

Withdrawn

• Conditions: Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium
• Interventions: Procedure: endometrial biopsy

• Registration Number: NCT03157765
• Lead Sponsor: Brown Fertility

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.

Study Timeline

• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-17
• Study Start: 2017-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EMB intervention	endometrial biopsy	These patients receive and endometrial biopsy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
miscarriage rate	within 18 months after recruitment	number of losses of clinical pregnancies divided by number of clinical pregnancies
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