Endometrial InjuryNCT04597463
The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of RIF
A study testing Endometrial injury in people with Endometrial Injury and Hysteroscopy, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 Read more about this study
- Who is it for?
- Ages 25 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Injury, Hysteroscopy, Repeated Implantation Failures
- What is being tested?
- Endometrial injury
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 2 Dec 2017to 2 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with RIF under 42 years old
- BMI 20-30
- Normal endometrial cavity
- FSH <15 IU/L
- Absence of immunological or hematological disorder
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- Endometrial injury
- Keywords
- Endometrial injury, Hysteroscopy, RIF, IVF, ART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial injuryProcedure or surgery
Endometrial injury was performed hysteroscopically after freeze all cycles and during the cycle before the frozen embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| Endometrial injury | Experimental | Endometrial injury before the embryo transfer of a frozen cycle Receives: Procedure: Endometrial injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 22 weeks
Secondary outcomes (2)
Physiological parameter -Clinical pregnancy rate
A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy
Measured: 7 weeks
Adverse event - Miscarriage
Spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start2 Dec 2017
- Primary completion2 Sep 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endometrial InjuryStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Endometrial injury in RIF patients
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IOANNIS RIGOS, National and Kapodistrian University of Athens
- Investigators
- Charalampos Siristatidis, Prof, Study director, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597463
- Sponsor's protocol ID
- 1811198218111982
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27629122Barash 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.
PubMed 12798877Wong 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.
PubMed 28349510
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of Repeated Implantation Failure.
- ClinicalTrials.gov ID
- NCT04597463
- Acronym / sponsor ID
- 1811198218111982
- Keywords
- Endometrial injury, Hysteroscopy, RIF, IVF, ART
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 2 Dec 2017 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Endometrial injury in RIF patients
| Arm | Type | Receives |
|---|---|---|
| Endometrial injury | Experimental | Procedure: Endometrial injuryEndometrial injury before the embryo transfer of a frozen cycle |
Who may qualify
- Ages
- 25 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with RIF under 42 years old
- BMI 20-30
- Normal endometrial cavity
- FSH <15 IU/L
- Absence of immunological or hematological disorder
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial injuryEndometrial injury was performed hysteroscopically after freeze all cycles and during the cycle before the frozen embryo transfer | Procedure or surgery | Endometrial injury |
Primary outcome
Physiological parameter - Live birth rate
Time frame: 22 weeks
The complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age
2 secondary outcomes
Physiological parameter -Clinical pregnancy rate
Time frame: 7 weeks
Adverse event - Miscarriage
Time frame: 22 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Background: PubMed 27629122Basile 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.
- Background: PubMed 12798877Barash 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.
- Background: PubMed 28349510Wong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charalampos Siristatidis, Prof study director
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial injury in people with Endometrial Injury and Hysteroscopy, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological parameter - Live birth rate (time frame: 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04597463, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.