Effect of Endometrial Scratching on Assisted Reproduction Outcomes: a Randomized Controlled Trial

NCT ID: NCT02180256

Last Updated: 2018-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Subfertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Endoscratching, non-RIF

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.

Group Type EXPERIMENTAL

Endometrial Scratching

Intervention Type PROCEDURE

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

Control, non-RIF

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Endoscratching, RIF

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.

Group Type EXPERIMENTAL

Endometrial Scratching

Intervention Type PROCEDURE

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

Control, RIF

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Endometrial Scratching

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

Intervention Type PROCEDURE

Other Intervention Names

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Endometrial injury Endometrial biopsy Endoscratching

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Wellington P Martins, MD

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wellington P Martins, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Hc-Fmrp-Usp

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 24835342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23754314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23339704 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22786529 (View on PubMed)

Other Identifiers

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CAAE: 30504514.6.0000.5440

Identifier Type: -

Identifier Source: org_study_id

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