Back to resultsThe Combination of Endometrial Injury and Freeze All Strategy in Women With a History of RIF
Primary Purpose
Endometrial Injury, Hysteroscopy, Repeated Implantation Failures
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Endometrial injury
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Injury focused on measuring Endometrial injury, Hysteroscopy, RIF, IVF, ART
Eligibility Criteria
Inclusion Criteria:
- Women with RIF under 42 years old
- BMI 20-30
- Normal endometrial cavity
- FSH <15 IU/L
- Absence of immunological or hematological disorder
Exclusion Criteria:
- women over 42 years old
- FSH>15 IU/L
- women with chronic immunological or hematological disorder
- stage III or IV of endometriosis
- women with pathology concerning the endometrial cavity
- women with a medical history of adnexectomy or oophorectomy
Sites / Locations
- National and Kapodistrian University of Athens
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endometrial injury
Arm Description
Endometrial injury before the embryo transfer of a frozen cycle
Outcomes
Primary Outcome Measures
Physiological parameter - Live birth rate
The complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age
Secondary Outcome Measures
Physiological parameter -Clinical pregnancy rate
A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy
Adverse event - Miscarriage
Spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age
Full Information
NCT ID
NCT04597463
First Posted
October 16, 2020
Last Updated
October 23, 2020
Sponsor
National and Kapodistrian University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT04597463
Brief Title
The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of RIF
Official Title
The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of Repeated Implantation Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 2, 2017 (Actual)
Primary Completion Date
September 2, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators checked the hypothesis whether endometrial injury performed during the cycle before a frozen embryo transfer in women with RIF can improve pregnancy rates
Detailed Description
After a freeze all cycle, participants were divided in two groups: an intervention group (n=30), who underwent endometrial injury before the transfer, and a control group (n=30), who underwent no other intervention. The primary outcome was clinical pregnancy rate, while secondary clinical and laboratory parameters. Baseline and cycle characteristics were also compared between groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Injury, Hysteroscopy, Repeated Implantation Failures
Keywords
Endometrial injury, Hysteroscopy, RIF, IVF, ART
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Endometrial injury in RIF patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endometrial injury
Arm Type
Experimental
Arm Description
Endometrial injury before the embryo transfer of a frozen cycle
Intervention Type
Procedure
Intervention Name(s)
Endometrial injury
Intervention Description
Endometrial injury was performed hysteroscopically after freeze all cycles and during the cycle before the frozen embryo transfer
Primary Outcome Measure Information:
Title
Physiological parameter - Live birth rate
Description
The complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
Physiological parameter -Clinical pregnancy rate
Description
A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy
Time Frame
7 weeks
Title
Adverse event - Miscarriage
Description
Spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age
Time Frame
22 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women with RIF under 42 years old
BMI 20-30
Normal endometrial cavity
FSH <15 IU/L
Absence of immunological or hematological disorder
Exclusion Criteria:
women over 42 years old
FSH>15 IU/L
women with chronic immunological or hematological disorder
stage III or IV of endometriosis
women with pathology concerning the endometrial cavity
women with a medical history of adnexectomy or oophorectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charalampos Siristatidis, Prof
Organizational Affiliation
National and Kapodistrian University of Athens
Official's Role
Study Director
Facility Information:
Facility Name
National and Kapodistrian University of Athens
City
Athens
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
27629122
Citation
Basile N, Garcia-Velasco JA. The state of "freeze-for-all" in human ARTs. J Assist Reprod Genet. 2016 Dec;33(12):1543-1550. doi: 10.1007/s10815-016-0799-9. Epub 2016 Sep 14.
Results Reference
background
PubMed Identifier
12798877
Citation
Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
Results Reference
background
PubMed Identifier
28349510
Citation
Wong KM, van Wely M, Mol F, Repping S, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2017 Mar 28;3(3):CD011184. doi: 10.1002/14651858.CD011184.pub2.
Results Reference
background
Learn more about this trial
The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of RIF
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