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

The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of Repeated Implantation Failure.

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

Study Overview

• Status: Completed
• Conditions: Hysteroscopy; Endometrial Injury; Repeated Implantation Failures
• Intervention / Treatment: Procedure: Endometrial injury

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • National and Kapodistrian University of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological parameter -Clinical pregnancy rate	A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy	7 weeks
Adverse event - Miscarriage	Spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age	22 weeks

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Investigators: Study Director: Charalampos Siristatidis, Prof, National and Kapodistrian University of Athens

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2017
• Primary Completion (Actual): September 2, 2020
• Study Completion (Actual): October 2, 2020

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 23, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: IVF; ART; Hysteroscopy; Endometrial injury; RIF
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 1811198218111982

Drug and device information, study documents

• 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