Repetitive Implantation FailureERANCT01668693
ERA Test in Patients With Recurrent Implantation Failure
A study testing ERA (Endometrial Receptivity Array), Personalized Embryo Transfer and Second ERA in people with Repetitive Implantation Failure, run by Igenomix at 1 site in Spain.
Trial summary
The purpose of this study is to demonstrate the clinical efficiency of the Endometrial Receptivity Array (ERA) diagnostic tool in patients with repetitive implantation failure (RIF), leading to the new concept of the personalized window of implantation (pWOI) as diagnostic and treatment of patients with RIF of… Read more about this study
- Who is it for?
- Ages 20 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Repetitive Implantation Failure
- What is being tested?
- ERA (Endometrial Receptivity Array), Personalized Embryo Transfer and Second ERA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Dec 2016
- 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 20 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women ≤38 years old
- Normal ovarian reserve
- FSH <8mIU/mL
- Cycle with ≥6 MII oocytes/oocyte retrieval
- ≥3 implantation failures in previous IVF/ICSI cycles with transfer of atleast two good quality embryos in each cycle Inclusion Criteria for ovum donation recipients
- ≥3 implantation failures with transfer of atleast two good quality embryos in each cycle
- Endometrial thickness ≥ 6 mm
- Trilaminar pattern after proper progesterone priming
Who cannot join
- Existance of hydrosalpinx
- Atrophic endometrium < 6 mm
- Previous ectopic or uterine miscarriages
- Presence of myomas or polyps
- Previous embryo transfer with high difficulty and/or bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Endometrial Receptivity Array (ERA) as Diagnosis and Personalized Embryo Transfer (pET) as Treatment in Patients With Receptive Implantation Failure (RIF).
The purpose of this study is to demonstrate the clinical efficiency of the Endometrial Receptivity Array (ERA) diagnostic tool in patients with repetitive implantation failure (RIF), leading to the new concept of the personalized window of implantation (pWOI) as diagnostic and treatment of patients with RIF of endometrial origin.
Read the detailed description
Intervention(s): Endometrial sampling, either at LH+7 in a natural cycle or after 5 days of progesterone in a hormonal replacement cycle (HRT) and personalized embryo transfer (pET) on the designated day guided by the ERA prediction.
Repeated implantation failure (RIF) is an unsolved not well characterized major cause of infertility in otherwise healthy women. Although various definitions of RIF exist, the clinical community agrees that after failure of three IVF cycles, in which one to two morphologically high-grade embryos have been transferred, special protocols must be enforced, although no hard data from RCTs demonstrates that any of the current approaches in RIF have a significant clinical value .
Based on the large amount of information generated about the regulation and deregulation of the genes implicated in the endometrial window of receptivity (WOR), our group has developed a molecular diagnostic tool based on the specific transcriptomic signature that identifies the receptive endometrium at LH+7 in a natural cycle or on day 5 of progesterone impregnation (P+5) after proper estradiol priming in a hormonal replacement therapy (HRT) cycle. The endometrial receptivity array (ERA) consists of a customized array containing 238 genes differentially expressed that is coupled to a computational predictor able to diagnose the personalized endometrial WOI of a given patient, regardless of its histological appearance. The accuracy of the diagnostic tool ERA has been demonstrated to be superior to endometrial histology and results are completely reproducible 29 to 40 months later.
Compelling evidence indicates the existence of an endometrial receptivity alteration in patients with RIF.
The aim of this study is to demonstrate the diagnostic efficiency of the ERA test in RIF patients by identifying putative alterations related to the displacement of their personalized window of receptivity, and the therapeutic implications through personalization of the day of embryo transfer (pET), following the diagnosis obtained by this molecular diagnostic tool. An endometrial biopsy on day LH+7 in a natural cycle or on day P+5 in an HRT cycle and ERA diagnosis of receptive or non-receptive is informed. In receptive cases, embryo transfer (ET) will be performed in subsequent cycles on the indicated day. In non-receptive ERA, the test is to be repeated on the dayindicated by the predictor, and personalized ET guided in subsequent cycles according to ERA diagnosis.
- Conditions
- Repetitive Implantation Failure
- Being tested
- ERA (Endometrial Receptivity Array), Personalized Embryo Transfer, Second ERA
- Keywords
- Endometrial receptivity, recurrent implantation failure, predictor tool, ERA, customized microarray, personalized embryo transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERA (Endometrial Receptivity Array)Other
The diagnostic tool ERA will be performed on all of the patients in order to allocate them in the group "Receptive" or "Non Receptive" and to predict the number of days of Progesterone administration necesary to obtain the "Receptive" prediction.
Personalized Embryo TransferOther
When the ERA indicates receptivity, the patient will undergo the embryo transfer on the day indicated by the diagnostic tool.
Second ERAOther
A second ERA will be performed to confirm receptivity after further administration of Progesterone.
| Study group | Role | What they receive |
|---|---|---|
| RIF ERA Receptive 1 | Active comparator | With the "receptive" results from the first Endometrial Receptivity Array (ERA), the patients will undergo embryo transfer on Day 5 of Progesterone administration in the cycle following the ERA diagnosis. Receives: Other: ERA (Endometrial Receptivity Array); Other: Personalized Embryo Transfer |
| RIF ERA Non Receptive | Experimental | The "Non Receptive" results of the ERA diagnotic tool will indicate how many more days of Progesterone are necesary in order to obtain the "Receptive" daignosis. A second ERA will take place to confirm receptivity and in the following cycle, the personalized embryo transfer will take place on the day predicted by this diagnostic tool. Receives: Other: ERA (Endometrial Receptivity Array); Other: Personalized Embryo Transfer; Other: Second ERA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of the Receptive or Non Receptive endometrial status according to the ERA test.
Measured: 1 months
Secondary outcomes (2)
Pregnancy
Measured: 6 weeks
Implantation
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startJan 2010
- Primary completionApr 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repetitive Implantation FailureStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Carlos Simon, Instituto Valenciano de Infertilidad, IVI VALENCIA
- Investigators
- Carlos Simón, MD PhD, Principal investigator, ºIGENOMIX / IVI Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668693
- Sponsor's protocol ID
- 0600-E-905-JH
- Acronym
- ERA
- Status last verified
- Oct 2015
- First submitted
- 13 Aug 2012
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Endometrial Receptivity Array (ERA) as Diagnosis and Personalized Embryo Transfer (pET) as Treatment in Patients With Receptive Implantation Failure (RIF).
- ClinicalTrials.gov ID
- NCT01668693
- Acronym / sponsor ID
- ERA / 0600-E-905-JH
- Conditions
- Repetitive Implantation Failure
- Keywords
- Endometrial receptivity, recurrent implantation failure, predictor tool, ERA, customized microarray, personalized embryo transfer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Aug 2012 (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.
The purpose of this study is to demonstrate the clinical efficiency of the Endometrial Receptivity Array (ERA) diagnostic tool in patients with repetitive implantation failure (RIF), leading to the new concept of the personalized window of implantation (pWOI) as diagnostic and treatment of patients with RIF of endometrial origin.
Detailed description
Intervention(s): Endometrial sampling, either at LH+7 in a natural cycle or after 5 days of progesterone in a hormonal replacement cycle (HRT) and personalized embryo transfer (pET) on the designated day guided by the ERA prediction.
Repeated implantation failure (RIF) is an unsolved not well characterized major cause of infertility in otherwise healthy women. Although various definitions of RIF exist, the clinical community agrees that after failure of three IVF cycles, in which one to two morphologically high-grade embryos have been transferred, special protocols must be enforced, although no hard data from RCTs demonstrates that any of the current approaches in RIF have a significant clinical value .
Based on the large amount of information generated about the regulation and deregulation of the genes implicated in the endometrial window of receptivity (WOR), our group has developed a molecular diagnostic tool based on the specific transcriptomic signature that identifies the receptive endometrium at LH+7 in a natural cycle or on day 5 of progesterone impregnation (P+5) after proper estradiol priming in a hormonal replacement therapy (HRT) cycle. The endometrial receptivity array (ERA) consists of a customized array containing 238 genes differentially expressed that is coupled to a computational predictor able to diagnose the personalized endometrial WOI of a given patient, regardless of its histological appearance. The accuracy of the diagnostic tool ERA has been demonstrated to be superior to endometrial histology and results are completely reproducible 29 to 40 months later.
Compelling evidence indicates the existence of an endometrial receptivity alteration in patients with RIF.
The aim of this study is to demonstrate the diagnostic efficiency of the ERA test in RIF patients by identifying putative alterations related to the displacement of their personalized window of receptivity, and the therapeutic implications through personalization of the day of embryo transfer (pET), following the diagnosis obtained by this molecular diagnostic tool. An endometrial biopsy on day LH+7 in a natural cycle or on day P+5 in an HRT cycle and ERA diagnosis of receptive or non-receptive is informed. In receptive cases, embryo transfer (ET) will be performed in subsequent cycles on the indicated day. In non-receptive ERA, the test is to be repeated on the dayindicated by the predictor, and personalized ET guided in subsequent cycles according to ERA diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIF ERA Receptive 1 | Active comparator | Other: ERA (Endometrial Receptivity Array), Other: Personalized Embryo TransferWith the "receptive" results from the first Endometrial Receptivity Array (ERA), the patients will undergo embryo transfer on Day 5 of Progesterone administration in the cycle following the ERA diagnosis. |
| RIF ERA Non Receptive | Experimental | Other: ERA (Endometrial Receptivity Array), Other: Personalized Embryo Transfer, Other: Second ERAThe "Non Receptive" results of the ERA diagnotic tool will indicate how many more days of Progesterone are necesary in order to obtain the "Receptive" daignosis. A second ERA will take place to confirm receptivity and in the following cycle, the personalized embryo transfer will take place on the day predicted by this diagnostic tool. |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women ≤38 years old
- Normal ovarian reserve
- FSH <8mIU/mL
- Cycle with ≥6 MII oocytes/oocyte retrieval
- ≥3 implantation failures in previous IVF/ICSI cycles with transfer of atleast two good quality embryos in each cycle Inclusion Criteria for ovum donation recipients
Key exclusion criteria (5 listed)
- Existance of hydrosalpinx
- Atrophic endometrium < 6 mm
- Previous ectopic or uterine miscarriages
- Presence of myomas or polyps
- Previous embryo transfer with high difficulty and/or bleeding
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 |
|---|---|---|
| ERA (Endometrial Receptivity Array)The diagnostic tool ERA will be performed on all of the patients in order to allocate them in the group "Receptive" or "Non Receptive" and to predict the number of days of Progesterone administration necesary to obtain the "Receptive" prediction. | Other | RIF ERA Non Receptive, RIF ERA Receptive 1 |
| Personalized Embryo TransferWhen the ERA indicates receptivity, the patient will undergo the embryo transfer on the day indicated by the diagnostic tool. | Other | RIF ERA Non Receptive, RIF ERA Receptive 1 |
| Second ERAA second ERA will be performed to confirm receptivity after further administration of Progesterone. | Other | RIF ERA Non Receptive |
Primary outcome
Detection of the Receptive or Non Receptive endometrial status according to the ERA test.
Time frame: 1 months
2 secondary outcomes
Pregnancy
Time frame: 6 weeks
Implantation
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
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.
Carlos Simón, MD PhD principal investigator
ºIGENOMIX / IVI 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 ERA (Endometrial Receptivity Array), Personalized Embryo Transfer and Second ERA in people with Repetitive Implantation Failure, run by Igenomix 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 8 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: status not confirmed, as of the sponsor's last update on 19 Oct 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Simón, MD PhD (+34963050900, carlos.simon@ivi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of the Receptive or Non Receptive endometrial status according to the ERA test. (time frame: 1 months). 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 19 Oct 2015.