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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium
• Intervention / Treatment: Procedure: endometrial biopsy

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EMB intervention; These patients receive and endometrial biopsy	Procedure: endometrial biopsy; endometrial biopsy
NO_INTERVENTION: Routine care; These patient receive routine care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brown Fertility

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2017
• Primary Completion (ANTICIPATED): June 1, 2019
• Study Completion (ANTICIPATED): June 1, 2019

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (ACTUAL): May 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: IVF; frozen embryo transfer; recurrent implantation failure; endometrial injury; endometrial scratch
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: EMB for RIP/FET

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No