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

Hysteroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597463
• Other study ID #: 1811198218111982
• Status: Completed
• Phase: N/A
• Start date: December 2, 2017
• Est. completion date: October 2, 2020

Study information

• Verified date: October 2020
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2, 2020
• Est. primary completion date: September 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Injury
• Hysteroscopy
• Repeated Implantation Failures
• Wounds and Injuries

Intervention

Procedure:
• Endometrial injury
Endometrial injury was performed hysteroscopically after freeze all cycles and during the cycle before the frozen embryo transfer

Locations

Country	Name	City	State
Greece	National and Kapodistrian University of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Adverse event - Miscarriage	Spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age	22 weeks