NCT03157765

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

May 16, 2017

Last Update Submit

January 21, 2019

Conditions

Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium

Keywords

recurrent implantation failurefrozen embryo transferIVFendometrial scratchendometrial injury

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • ongoing pregnancy rate

    within 18 months of recruitment

  • biochemical pregnancy rate

    within 6 months after recruitment

  • miscarriage rate

    within 18 months after recruitment

Study Arms (2)

EMB intervention

EXPERIMENTAL

These patients receive and endometrial biopsy

Procedure: endometrial biopsy

Routine care

NO INTERVENTION

These patient receive routine care

Interventions

endometrial biopsyPROCEDURE

endometrial biopsy

EMB intervention

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Alternate explanation for implantation failure (e.g., intrauterine pathology)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 17, 2017

Study Start

June 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

January 23, 2019

Record last verified: 2019-01