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The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of RIF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04597463
Recruitment Status : Completed
First Posted : October 22, 2020
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
IOANNIS RIGOS, National and Kapodistrian University of Athens

Study Description
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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

Condition or disease Intervention/treatment Phase
Endometrial Injury Hysteroscopy Repeated Implantation Failures Procedure: Endometrial injury Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Endometrial injury in RIF patients
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of Repeated Implantation Failure.
Actual Study Start Date : December 2, 2017
Actual Primary Completion Date : September 2, 2020
Actual Study Completion Date : October 2, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Endometrial injury
Endometrial injury before the embryo transfer of a frozen cycle
 Procedure: Endometrial injury
Endometrial injury was performed hysteroscopically after freeze all cycles and during the cycle before the frozen embryo transfer


Outcome Measures
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Primary Outcome Measures :
  1. Physiological parameter - Live birth rate [ Time Frame: 22 weeks ]
    The complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age


Secondary Outcome Measures :
  1. Physiological parameter -Clinical pregnancy rate [ Time Frame: 7 weeks ]
    A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy

  2. Adverse event - Miscarriage [ Time Frame: 22 weeks ]
    Spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04597463


Locations
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Greece
National and Kapodistrian University of Athens
Athens, Greece
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
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Study Director: Charalampos Siristatidis, Prof National and Kapodistrian University of Athens
More Information
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Publications:

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Responsible Party: IOANNIS RIGOS, Principal Investigator, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT04597463    
Other Study ID Numbers: 1811198218111982
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020

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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
Keywords provided by IOANNIS RIGOS, National and Kapodistrian University of Athens:
Endometrial injury
Hysteroscopy
RIF
IVF
ART
Additional relevant MeSH terms:
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Wounds and Injuries