Back to resultsEndometrial Scratching for Cryopreserved Embryo Transfer
Primary Purpose
Subfertility
Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Endometrial injury
Sponsored by
About this trial
This is an interventional other trial for Subfertility
Eligibility Criteria
Inclusion Criteria:
- Age > 18
- At least one cryopreserved embryo
Exclusion Criteria:
- None
Sites / Locations
- Setor de Reprodução Humana - FMRP-USP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Endometrial injury
Control
Arm Description
Women allocated to this group will be submitted to endometrial injury before undergoing endometrial preparation for embryo transfer.
Women allocated to this group will NOT be submitted to endometrial injury before undergoing endometrial preparation for embryo transfer.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Miscarriage
The spontaneous loss of a clinical pregnancy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02093442
Brief Title
Endometrial Scratching for Cryopreserved Embryo Transfer
Official Title
Endometrial Scratching for Cryopreserved Embryo Transfer: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
The main investigators are no longer working at the center.
Study Start Date
July 2014 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endometrial injury
Arm Type
Experimental
Arm Description
Women allocated to this group will be submitted to endometrial injury before undergoing endometrial preparation for embryo transfer.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Women allocated to this group will NOT be submitted to endometrial injury before undergoing endometrial preparation for embryo transfer.
Intervention Type
Procedure
Intervention Name(s)
Endometrial injury
Other Intervention Name(s)
Endometrial scratching
Intervention Description
Endometrial biopsy using a pipelle de Cornier
Primary Outcome Measure Information:
Title
Live birth
Description
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.
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Clinical pregnancy
Description
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.
Time Frame
3 months
Title
Miscarriage
Description
The spontaneous loss of a clinical pregnancy
Time Frame
5 months
Other Pre-specified Outcome Measures:
Title
Multiple pregnancy
Description
A pregnancy with more than one gestational sac.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18
At least one cryopreserved embryo
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wellington P Martins, Ph.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Setor de Reprodução Humana - FMRP-USP
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14048-900
Country
Brazil
12. IPD Sharing Statement
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Endometrial Scratching for Cryopreserved Embryo Transfer
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