MedDataX Logo

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

NCT ID: NCT04597463

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-02

Study Completion Date

2020-10-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometrial Injury Hysteroscopy Repeated Implantation Failures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Endometrial injury in RIF patients
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endometrial injury

Endometrial injury before the embryo transfer of a frozen cycle

Group Type EXPERIMENTAL

Endometrial injury

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endometrial injury

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

IOANNIS RIGOS

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Charalampos Siristatidis, Prof

Role: STUDY_DIRECTOR

National and Kapodistrian University of Athens

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National and Kapodistrian University of Athens

Athens, , Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Greece

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27629122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12798877 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28349510 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1811198218111982

Identifier Type: -

Identifier Source: org_study_id