NCT02180256

Brief Summary

To examine whether endometrial scratching (or injury) using a Pipelle endometrial sampler, performed on the first seven days of the menstrual cycle, is able to improve pregnancy rates in women who will be submitted to a fresh embryo transfer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.8 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

1.8 years

First QC Date

June 30, 2014

Last Update Submit

May 7, 2018

Conditions

Subfertility

Keywords

IVFICSIEmbryo transferAssisted reproductionEndometrial injuryEndometrial scratching

Outcome Measures

Primary Outcomes (1)

  • Live birth

    The number of participants who delivered a living baby in each arm. The denominator will be the number of women randomized to each arm. This outcome will be assessed by examining the medical records and telephone contact.

    1 year

Secondary Outcomes (3)

  • Clinical pregnancy

    8 weeks

  • Miscarriage

    20 weeks

  • Multiple pregnancy

    8 weeks

Other Outcomes (1)

  • Implantation rate

    8 weeks

Study Arms (4)

Endoscratching, non-RIF

EXPERIMENTAL

Endometrial scratching. Women with no more than 1 previous unsuccessful embryo transfer. Pipelle in the first seven days of the menstrual cycle, just before starting controlled ovarian stimulation.

Procedure: Endometrial Scratching

Control, non-RIF

NO INTERVENTION

No intervention. Women with no more than 1 previous unsuccessful embryo transfer.

Endoscratching, RIF

EXPERIMENTAL

Endometrial scratching. Women with 2 or more previous unsuccessful embryo transfers. Pipelle in the first seven days of the menstrual cycle, just before starting controlled ovarian stimulation.

Procedure: Endometrial Scratching

Control, RIF

NO INTERVENTION

No intervention. Women with 2 or more previous unsuccessful embryo transfers.

Interventions

Endometrial ScratchingPROCEDURE

The intentional damage to the endometrium performed with the objective of improving the reproductive outcomes of women desiring pregnancy.

Also known as: Endometrial injury, Endometrial biopsy, Endoscratching
Endoscratching, RIFEndoscratching, non-RIF

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • First four days of the menstrual cycle, just before starting controlled ovarian stimulation for planned IVF and fresh embryo transfer.
  • Not have performed endometrial scratching in the last 90 days.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hc-Fmrp-Usp

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Related Publications (4)

  • Nastri CO, Teixeira DM, Ferriani RA, Martins WP. The overlooked endometrial injury underlying hysteroscopy procedures. Reprod Biomed Online. 2014 Jul;29(1):140. doi: 10.1016/j.rbmo.2014.03.021. Epub 2014 Apr 28. No abstract available.

    PMID: 24835342BACKGROUND

  • Nastri CO, Ferriani RA, Raine-Fenning N, Martins WP. Endometrial scratching performed in the non-transfer cycle and outcome of assisted reproduction: a randomized controlled trial. Ultrasound Obstet Gynecol. 2013 Oct;42(4):375-82. doi: 10.1002/uog.12539. Epub 2013 Sep 2.

    PMID: 23754314BACKGROUND

  • Nastri CO, Teixeira DM, Martins WP. Endometrial injury in the menstrual cycle prior to assisted reproduction techniques to improve reproductive outcomes. Gynecol Endocrinol. 2013 May;29(5):401-2. doi: 10.3109/09513590.2012.760193. Epub 2013 Jan 22. No abstract available.

    PMID: 23339704BACKGROUND

  • Nastri CO, Gibreel A, Raine-Fenning N, Maheshwari A, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009517. doi: 10.1002/14651858.CD009517.pub2.

    PMID: 22786529BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Wellington P Martins, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 2, 2014

Study Start

September 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)