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

• Sponsor: National and Kapodistrian University of Athens (Other)
• Overall Status: Completed
• CT.gov ID: NCT04597463
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Actual Duration (Months): 34
• Patients Per Site Per Month: 1.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Endometrial Injury; Hysteroscopy; Repeated Implantation Failures	Procedure: Endometrial injury	N/A

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

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Endometrial injury in RIF patientsEndometrial 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: Dec 2, 2017
• Actual Primary Completion Date: Sep 2, 2020
• Actual Study Completion Date: Oct 2, 2020

Arms and Interventions

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

Primary Outcome Measures

1. Physiological parameter - Live birth rate [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 [7 weeks]

   A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy

2. Adverse event - Miscarriage [22 weeks]

   Spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 42 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	National and Kapodistrian University of Athens	Athens		Greece

Sponsors and Collaborators

• National and Kapodistrian University of Athens

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.
• Basile N, Garcia-Velasco JA. The state of "freeze-for-all" in human ARTs. J Assist Reprod Genet. 2016 Dec;33(12):1543-1550. Epub 2016 Sep 14. Review.
• 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:CD011184. doi: 10.1002/14651858.CD011184.pub2. Review. Update in: Cochrane Database Syst Rev. 2021 Feb 4;2:CD011184.

• Responsible Party: IOANNIS RIGOS, Principal Investigator, National and Kapodistrian University of Athens
• ClinicalTrials.gov Identifier: NCT04597463
• Other Study ID Numbers: 1811198218111982
• First Posted: Oct 22, 2020
• Last Update Posted: Oct 27, 2020
• Last Verified: Oct 1, 2020

• 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, Principal Investigator, National and Kapodistrian University of Athens: Endometrial injury; Hysteroscopy; RIF; IVF; ART
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Oct 27, 2020