Endometrial Scratching for Cryopreserved Embryo Transfer

Endometrial Scratching for Cryopreserved Embryo Transfer: a Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Subfertility
• Intervention / Treatment: Procedure: Endometrial injury

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Ribeirao Preto, SP, Brazil, 14048-900
      • Setor de Reprodução Humana - FMRP-USP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age > 18
• At least one cryopreserved embryo

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endometrial injury; Women allocated to this group will be submitted to endometrial injury before undergoing endometrial preparation for embryo transfer.	Procedure: Endometrial injury; Endometrial biopsy using a pipelle de Cornier; Other Names: Endometrial scratching
No Intervention: Control; Women allocated to this group will NOT be submitted to endometrial injury before undergoing endometrial preparation for embryo transfer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy	A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Note: Multiple gestational sacs are counted as one clinical pregnancy.	3 months
Miscarriage	The spontaneous loss of a clinical pregnancy	5 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multiple pregnancy	A pregnancy with more than one gestational sac.	3 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Wellington P Martins, Ph.D., University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 21, 2014

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: CAAE:03292412.0.0000.5440