SterilityNCT01955356
Embryo Implantation After Induced Endometrial Injury
A study testing Scratching in people with Sterility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
Some studies have revealed that an induced endometrial injury could improve embryo human implantation in patients with implantation failure. The purpose of this study is to determine whether the induced endometrial injury could be beneficial for regular patients undergoing IVF Read more about this study
- Who is it for?
- Ages 19 to 44 years, women only
- Conditions the study is for
- Sterility
- What is being tested?
- Scratching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to 21 Nov 2022
- 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 19 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 19-44 aged women
- 19-29.9 Kg/m2.
- 1st or 2nd fresh embryo transfer ( egg donation).
- 1 or 2 blastocysts available.
- written agreement.
- > or = 6 mms endometrial thickness.
Who cannot join
- Premature ovarian failure.
- Endometrial pathology.
- Insufficient endometrial development.
- Hydrosalpinx
- Mullerian malformations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Induced Endometrial Injury in the Subsequent IVF Cycle.
Some studies have revealed that an induced endometrial injury could improve embryo human implantation in patients with implantation failure.
The purpose of this study is to determine whether the induced endometrial injury could be beneficial for regular patients undergoing IVF
Read the detailed description
Endometrial induced injury has been suggested that could improve embryo implantation in cases of patients with recurrent implantation failure. The mechanisms that induce that improvement remain unknown.
We want to analyse if the endometrial induce injury could be useful in cases of standard patients who require assisted reproductive techniques.
For that purpose we will start a randomized controlled trial with the ideal background in implantation in ART, the egg donation programme.
- Conditions
- Sterility
- Being tested
- Scratching
- Keywords
- Scratching, Endometrial biopsy, Ongoing embryo implantation, Assisted reproductive techniques
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScratchingProcedure or surgery
Also called Endometrial induced injury
Endometrial biopsy
| Study group | Role | What they receive |
|---|---|---|
| Scratching | Experimental | induced endometrial injury Receives: Procedure: Scratching |
| No scratching | No intervention | None intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing implantation rate (OIR)
Measured: 12 weeks of pregnancy
Secondary outcomes (1)
Live born rate (LBR)
Measured: 9 months after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startOct 2013
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SterilityStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Collaborators
- IVI Madrid, IVI Barcelona, IVI Murcia, Vida Recoletas Sevilla, IVI Bilbao, IVI Vigo, Instituto Valenciano de Infertilidad, IVI Alicante
- Responsible party
- Principal investigator, Carmina Vidal, MD, Instituto Valenciano de Infertilidad, IVI VALENCIA
- Investigators
- Carmina Vidal, MD, Principal investigator, IV VALENCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955356
- Sponsor's protocol ID
- 1306-C-119-CV/IVI Valencia
- Status last verified
- Jan 2023
- First submitted
- 28 Sep 2013
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Induced Endometrial Injury in the Subsequent IVF Cycle.
- ClinicalTrials.gov ID
- NCT01955356
- Acronym / sponsor ID
- 1306-C-119-CV/IVI Valencia
- Conditions
- Sterility
- Keywords
- Scratching, Endometrial biopsy, Ongoing embryo implantation, Assisted reproductive techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Collaborators
- IVI Madrid, IVI Barcelona, IVI Murcia, Vida Recoletas Sevilla, IVI Bilbao, IVI Vigo, Instituto Valenciano de Infertilidad, IVI Alicante
- Study start
- Oct 2013 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 7 Oct 2013 (estimated)
- 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.
Some studies have revealed that an induced endometrial injury could improve embryo human implantation in patients with implantation failure.
The purpose of this study is to determine whether the induced endometrial injury could be beneficial for regular patients undergoing IVF
Detailed description
Endometrial induced injury has been suggested that could improve embryo implantation in cases of patients with recurrent implantation failure. The mechanisms that induce that improvement remain unknown.
We want to analyse if the endometrial induce injury could be useful in cases of standard patients who require assisted reproductive techniques.
For that purpose we will start a randomized controlled trial with the ideal background in implantation in ART, the egg donation programme.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scratching | Experimental | Procedure: Scratchinginduced endometrial injury |
| No scratching | No intervention | –None intervention |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 19-44 aged women
- 19-29.9 Kg/m2.
- 1st or 2nd fresh embryo transfer ( egg donation).
- 1 or 2 blastocysts available.
- written agreement.
Key exclusion criteria (5 listed)
- Premature ovarian failure.
- Endometrial pathology.
- Insufficient endometrial development.
- Hydrosalpinx
- Mullerian malformations.
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 |
|---|---|---|
| ScratchingAlso: Endometrial induced injuryEndometrial biopsy | Procedure or surgery | Scratching |
Primary outcome
Ongoing implantation rate (OIR)
Time frame: 12 weeks of pregnancy
1 secondary outcome
Live born rate (LBR)
Time frame: 9 months after embryo transfer
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 11 Jan 2023.
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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.
Carmina Vidal, MD principal investigator
IV VALENCIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scratching in people with Sterility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
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 6 inclusion and 5 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 11 Jan 2023. 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 Spain. 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?
Ongoing implantation rate (OIR) (time frame: 12 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2023.