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Effect of endometrial scratching on assisted reproduction outcome: randomized controlled trial

Grant number: 14/11225-6
Support type:Scholarships in Brazil - Post-Doctorate
Effective date (Start): September 01, 2014
Effective date (End): August 31, 2016
Field of knowledge:Health Sciences - Medicine - Maternal and Child Health
Cooperation agreement: Coordination of Improvement of Higher Education Personnel (CAPES)
Principal Investigator:Wellington de Paula Martins
Grantee:Carolina Oliveira Nastri Martins
Home Institution: Faculdade de Medicina de Ribeirão Preto (FMRP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil

Abstract

Introduction: Endometrial scratching performed in the previous cycle of assisted reproduction treatment (ART) is a procedure used to increase the chances of pregnancy. However, its efficacy has been studied only when performed in the previous ART cycle on patients with two or more previous failures. Objectives: To evaluate the effect of endometrial scratching performed during the menstrual period (first four days of the cycle) on reproductive outcomes in women undergoing IVF/ICSI with either fresh or cryopreserved embryo transfer. Methods: A randomized controlled open-label trial, with allocation of subjects into two parallel groups in a 1:1 ratio. The allocation will be made stratifying the subjects in one of 3 groups: (1) fresh embryo transfer in women with only one prior failure, (2) fresh embryo transfer in women with two or more previous failures and (3) cryopreserved embryo transfer. The primary outcome will be clinical pregnancy; and secondary outcomes will be live birth, miscarriage and multiple pregnancy. For ethical reasons four interim analyzes and one final analysis were planned. Because of multiple analyzes issues the level of significance was set at 0.01 and is scheduled to include 900 participants. (AU)