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

Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03157765
• Other study ID #: EMB for RIP/FET
• Status: Withdrawn
• Phase: N/A
• Start date: June 2017
• Est. completion date: June 2019

Study information

• Verified date: January 2019
• Source: Brown Fertility
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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)

Related Conditions & MeSH terms

• Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium

Intervention

Procedure:
• endometrial biopsy
endometrial biopsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brown Fertility

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation rate	Sacs seen in early ultrasound divided by the number of embryos transferred	within 6 months after recruitment
Primary	clinical pregnancy rate	Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers	within 6 months after recruitment
Secondary	ongoing pregnancy rate	Viable or delivered pregnancies at conclusion of study divided by the number of embryo transfers	within 18 months of recruitment
Secondary	biochemical pregnancy rate	number of positive pregnancy test divided by number of embryo transfers	within 6 months after recruitment
Secondary	miscarriage rate	number of losses of clinical pregnancies divided by number of clinical pregnancies	within 18 months after recruitment