NCT02093442

Brief Summary

Endometrial injury performed in a cycle preceding the one for embryo transfer is associated with an increased implantation and pregnancy rate when carried out during the month preceding that of ovulation induction and fresh embryo transfer. However, there is no evidence about the effect of this intervention on the transfer of cryopreserved embryos.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

March 18, 2014

Last Update Submit

May 7, 2018

Conditions

Subfertility

Outcome Measures

Primary Outcomes (1)

  • Live birth

    The complete expulsion or extraction from its mother of a product of fertilization, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached.

    10 months

Secondary Outcomes (2)

  • Clinical pregnancy

    3 months

  • Miscarriage

    5 months

Other Outcomes (1)

  • Multiple pregnancy

    3 months

Study Arms (2)

Endometrial injury

EXPERIMENTAL

Women allocated to this group will be submitted to endometrial injury before undergoing endometrial preparation for embryo transfer.

Procedure: Endometrial injury

Control

NO INTERVENTION

Women allocated to this group will NOT be submitted to endometrial injury before undergoing endometrial preparation for embryo transfer.

Interventions

Endometrial injuryPROCEDURE

Endometrial biopsy using a pipelle de Cornier

Also known as: Endometrial scratching
Endometrial injury

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age \> 18
  • At least one cryopreserved embryo

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Setor de Reprodução Humana - FMRP-USP

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Wellington P Martins, Ph.D.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 21, 2014

Study Start

July 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 14, 2018

Record last verified: 2018-05

Locations

BR(1)