The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of RIF
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2020
CompletedFirst Submitted
Initial submission to the registry
October 16, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedOctober 27, 2020
October 1, 2020
2.8 years
October 16, 2020
October 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
22 weeks
Secondary Outcomes (2)
Physiological parameter -Clinical pregnancy rate
7 weeks
Adverse event - Miscarriage
22 weeks
Study Arms (1)
Endometrial injury
EXPERIMENTALEndometrial injury before the embryo transfer of a frozen cycle
Interventions
Endometrial injury was performed hysteroscopically after freeze all cycles and during the cycle before the frozen embryo transfer
Eligibility Criteria
You may qualify if:
- Women with RIF under 42 years old
- BMI 20-30
- Normal endometrial cavity
- FSH \<15 IU/L
- Absence of immunological or hematological disorder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National and Kapodistrian University of Athens
Athens, Greece
Related Publications (3)
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.
PMID: 27629122BACKGROUNDBarash 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.
PMID: 12798877BACKGROUNDWong 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.
PMID: 28349510BACKGROUND
Study Officials
- STUDY DIRECTOR
Charalampos Siristatidis, Prof
National and Kapodistrian University of Athens
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 16, 2020
First Posted
October 22, 2020
Study Start
December 2, 2017
Primary Completion
September 2, 2020
Study Completion
October 2, 2020
Last Updated
October 27, 2020
Record last verified: 2020-10