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

Not Applicable

Completed

• Conditions: Endometrial Injury; Repeated Implantation Failures; Hysteroscopy
• Interventions: Procedure: Endometrial injury

• Registration Number: NCT04597463
• Lead Sponsor: National and Kapodistrian University of Athens

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.

Study Timeline

• Study Start: 2017-12-02
• Primary Completion: 2020-09-02
• Status Verified: 2020-10
• Study Completion: 2020-10-02
• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-22
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endometrial injury	Endometrial injury	Endometrial injury before the embryo transfer of a frozen cycle

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse event - Miscarriage	22 weeks	Spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age
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

Trial Locations

Locations (1)

National and Kapodistrian University of Athens; 🇬🇷 Athens, Greece