Endometrial ReceptivityERA RCTNCT01954758
The ERA Test as a Diagnostic Guide for Personalized Embryo Transfer
A study testing personalized Embryo Transfer (pET), Frozen Embryo Transfer (FET) and Fresh Embryo Transfer (ET) in people with Endometrial Receptivity, run by Igenomix at 16 sites in 7 countries.
Trial summary
This project seeks to demonstrate the clinical value of the personalised diagnosis of the endometrial factor in infertility. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Endometrial Receptivity
- What is being tested?
- personalized Embryo Transfer (pET), Frozen Embryo Transfer (FET) and Fresh Embryo Transfer (ET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 569 participants
- Where
- 16 sitesin 7 countries
- Study dates
- 25 Nov 2013to 31 Aug 2018
- 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 18 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients indicated to undergo a cycle of IVF/ICSI with their own oocytes.
- Age ≤ 37 years
- BMI: 18.5 to 30
- Normal ovarian reserve (AFC ≥ 8; FSH < 8)
- The most appropriated stimulation protocol will be decided by their doctor.
- Blastocyst transfer (on day 5 or 6)
- Blastocyst vitrification with open protocols (Cryotop, Cryoleaf, or Cryolock) or closed protocols (Cryotip or CBSStraw.)
- Any pathology affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas > 4 cm, or hydrosalpinx affecting the endometrial cavity must be previously operated.
Who cannot join
- Patients with recurrent miscarriages (> 2 previous biochemical pregnancies or > 2 spontaneous miscarriages)
- Patients with a severe male factor (spermatozoa < 2 million/ml)
- Patients with implantation failure (>3 failed cycles with good quality embryos)
- Post-Randomization Exclusion Criteria:
- Endogenous progesterone level ≥ 1,5 ng/ml at the day of hCG administration in all groups.
- Absence of blastocysts (day 5 or 6) for embryo transfer.
- Risk of ovarian hyperstimulation syndrome in any of the three groups and therefore a clinical indication to cancel the transfer cycle where the stimulated patient is from group A (ET).
- Note: PGT-A is not an inclusion criteria neither an exclusion criteria, therefore those cycles in which PGT-A was performed will be included
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
Spain8 sites
IVI Alicante
Alicante, 03015
IVI Madrid
Aravaca, Madrid, 24527
IVI Barcelona
Barcelona, 08017
IVI Bilbao
Leioa, Bizkaia, 48940
ProcreaTec
Madrid, 28036
IVI Sevilla
Seville, 41011
IVI Valencia
Valencia, 46015
IVI Vigo
Vigo, Pontevedra, 36203
Brazil3 sites
Centro de Infertilidade e Medicina Fetal do Norte Fluminence
Campos dos Goytacazes, Rio de Janeiro, 28035-210
Centro de Reproduçao Humana Nilo Frantz
Porto Alegre, Rio Grande do Sul
Centro de Reprodução Governador Mario Covas
São Paulo
Bulgaria1 site
Sofia Hospital of Reproductive Medicine - SBALAGRM
Sofia, 1000
About this study
Official title: Clinical Study, International, Multicentre, Prospective, Randomised, Interventional and Controlled, Comparing Fresh Embryo Transfer (ET) Versus Frozen Embryo Transfer (FET) and Personalised Embryo Transfer (pET) Guided by the ERA (Endometrial Receptivity Analysis) Test as a Diagnostic Tool in Patients Treated by IVF/ICSI (in Vitro Fertilisation; Intra-cytoplasmic Sperm Injection)
This project seeks to demonstrate the clinical value of the personalised diagnosis of the endometrial factor in infertility.
Read the detailed description
This project seeks to investigate differences in implantation (IR), pregnancy (PR), ongoing pregnancy (OP) rates, miscarriages, deliveries (LB) and obstetrical, delivery and neonatal outcomes among women undergoing IVF treatment with own oocytes, at first site appointment (up to 3 previous implantation failures in other sites) and blastocyst stage (day 5 or 6). Patients are allocated through computer-generated randomization into one of the three groups: Fresh embryo transfer (ET), Frozen embryo transfer (FET) or personalized embryo transfer (pET) after identification of the personalized window of implantation using the endometrial receptivity analysis (ERA) test, all of them following the usual clinical practice in a same-cycle embryo transfer.
A total of 546 infertile women under 38 years old undergoing her first IVF/ICSI cycle with elective blastocyst transfer are randomized in this prospective, multicenter, open label and controlled trial.
- Conditions
- Endometrial Receptivity
- Being tested
- personalized Embryo Transfer (pET), Frozen Embryo Transfer (FET), Fresh Embryo Transfer (ET)
- Keywords
- Window of implantation, Personalized embryo transfer, Fresh embryo transfer, Delayed embryo transfer, Elective deferred embryo transfer, Endometrial receptivity array, Endometrial receptivity analysis, Endometrial receptivity test, Frozen embryo transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized Embryo Transfer (pET)Other
Frozen Embryo Transfer (FET)Other
Fresh Embryo Transfer (ET)Other
| Study group | Role | What they receive |
|---|---|---|
| Personalized embryo transfer (pET) | Experimental | Patients will undergo a cycle of endometrial preparation following hormone replacement therapy (HRT) and an endometrial biopsy in a substituted cycle after 5 days (around 120 hours) of progesterone administration. The ERA test will determine the window of implantation (WOI) for each patient and will recommend the best time for embryo transfer thereby increasing the chances of a successful outcome. In some specific cases (≤ 10%) a second biopsy will be required to help the bioinformatic predictor to ensure the most appropriated moment for the embryo transfer. In a different cycle, patients will undergo a cycle of controlled ovarian stimulation (COS) to obtain oocytes which will be fertilized by IVF/ICSI and vitrified. In a subsequent cycle, following the ERA result, a personalized embryo transfer (pET) will be carried out following the same conditions in which the ERA test was obtained, using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage) Receives: Other: personalized Embryo Transfer (pET) |
| Frozen embryo transfer (FET) | Active comparator | Patients will undergo a cycle of controlled ovarian stimulation (COS) to obtain oocytes which will be fertilized by IVF/ICSI. In a subsequent cycle, following hormone replacement therapy (HRT), a frozen embryo transfer (FET) will be performed using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage). Receives: Other: Frozen Embryo Transfer (FET) |
| Fresh embryo transfer (ET) | Active comparator | Patients will undergo a controlled ovarian stimulation cycle (COS) to obtain oocytes which will be fertilized by IVF/ICSI. In the same cycle, a fresh embryo transfer will be performed using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage). Receives: Other: Fresh Embryo Transfer (ET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth delivery rate
Percentage of deliveries that resulted in at least one live birth per embryo transfer.
Measured: 40 weeks
Secondary outcomes (8)
Implantation rate
The percentage of gestational sacs observed divided by the number of embryos transferred
Measured: 12 weeks
Pregnancy rate
The percentage of positive pregnancy test divided by the number of embryo transfers
Measured: 20 weeks
Biochemical pregnancies
A pregnancy diagnosed only by the detection of beta hCG in serum
Measured: 20 weeks
Ectopic pregnancies
A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology
Measured: 20 weeks
Clinical miscarriages
Spontaneous loss of a clinical pregnancy before 20 completed weeks of gestational age
Measured: 20 weeks
Cumulative pregnancy rate
Cumulative pregnancy rate in the 12 months after the first study embryo transfer
Measured: 12 months
Cumulative implantation rate
Cumulative implantation rate in the 12 months after the first study embryo transfer
Measured: 12 months
Cumulative live birth delivery rate
Cumulative live birth delivery rate per embryo transfer in the 12 months after the first study embryo transfer
Measured: 12 months
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 start25 Nov 2013
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial ReceptivityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 569 participants (actual)
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 Simon, MDPhD, Principal investigator, IVI Valencia / Igenomix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954758
- Sponsor's protocol ID
- 1304-C-107-CS
- Acronym
- ERA RCT
- Status last verified
- Feb 2019
- First submitted
- 26 Sep 2013
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Katzorke N, Vilella F, Ruiz M, Krussel JS, Simon C. Diagnosis of Endometrial-Factor Infertility: Current Approaches and New Avenues for Research. Geburtshilfe Frauenheilkd. 2016 Jun;76(6):699-703. doi: 10.1055/s-0042-103752.
PubMed 27365540
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study, International, Multicentre, Prospective, Randomised, Interventional and Controlled, Comparing Fresh Embryo Transfer (ET) Versus Frozen Embryo Transfer (FET) and Personalised Embryo Transfer (pET) Guided by the ERA (Endometrial Receptivity Analysis) Test as a Diagnostic Tool in Patients Treated by IVF/ICSI (in Vitro Fertilisation; Intra-cytoplasmic Sperm Injection)
- ClinicalTrials.gov ID
- NCT01954758
- Acronym / sponsor ID
- ERA RCT / 1304-C-107-CS
- Conditions
- Endometrial Receptivity
- Keywords
- Window of implantation, Personalized embryo transfer, Fresh embryo transfer, Delayed embryo transfer, Elective deferred embryo transfer, Endometrial receptivity array, Endometrial receptivity analysis, Endometrial receptivity test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2013 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (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.
This project seeks to demonstrate the clinical value of the personalised diagnosis of the endometrial factor in infertility.
Detailed description
This project seeks to investigate differences in implantation (IR), pregnancy (PR), ongoing pregnancy (OP) rates, miscarriages, deliveries (LB) and obstetrical, delivery and neonatal outcomes among women undergoing IVF treatment with own oocytes, at first site appointment (up to 3 previous implantation failures in other sites) and blastocyst stage (day 5 or 6). Patients are allocated through computer-generated randomization into one of the three groups: Fresh embryo transfer (ET), Frozen embryo transfer (FET) or personalized embryo transfer (pET) after identification of the personalized window of implantation using the endometrial receptivity analysis (ERA) test, all of them following the usual clinical practice in a same-cycle embryo transfer.
A total of 546 infertile women under 38 years old undergoing her first IVF/ICSI cycle with elective blastocyst transfer are randomized in this prospective, multicenter, open label and controlled trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized embryo transfer (pET) | Experimental | Other: personalized Embryo Transfer (pET)Patients will undergo a cycle of endometrial preparation following hormone replacement therapy (HRT) and an endometrial biopsy in a substituted cycle after 5 days (around 120 hours) of progesterone administration. The ERA test will determine the window of implantation (WOI) for each patient and will recommend the best time for embryo transfer thereby increasing the chances of a successful outcome. In some specific cases (≤ 10%) a second biopsy will be required to help the bioinformatic predictor to ensure the most appropriated moment for the embryo transfer. In a different cycle, patients will undergo a cycle of controlled ovarian stimulation (COS) to obtain oocytes which will be fertilized by IVF/ICSI and vitrified. In a subsequent cycle, following the ERA result, a personalized embryo transfer (pET) will be carried out following the same conditions in which the ERA test was obtained, using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage) |
| Frozen embryo transfer (FET) | Active comparator | Other: Frozen Embryo Transfer (FET)Patients will undergo a cycle of controlled ovarian stimulation (COS) to obtain oocytes which will be fertilized by IVF/ICSI. In a subsequent cycle, following hormone replacement therapy (HRT), a frozen embryo transfer (FET) will be performed using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage). |
| Fresh embryo transfer (ET) | Active comparator | Other: Fresh Embryo Transfer (ET)Patients will undergo a controlled ovarian stimulation cycle (COS) to obtain oocytes which will be fertilized by IVF/ICSI. In the same cycle, a fresh embryo transfer will be performed using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage). |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients indicated to undergo a cycle of IVF/ICSI with their own oocytes.
- Age ≤ 37 years
- BMI: 18.5 to 30
- Normal ovarian reserve (AFC ≥ 8; FSH < 8)
- The most appropriated stimulation protocol will be decided by their doctor.
Key exclusion criteria (8 listed)
- Patients with recurrent miscarriages (> 2 previous biochemical pregnancies or > 2 spontaneous miscarriages)
- Patients with a severe male factor (spermatozoa < 2 million/ml)
- Patients with implantation failure (>3 failed cycles with good quality embryos)
- Endogenous progesterone level ≥ 1,5 ng/ml at the day of hCG administration in all groups.
- Absence of blastocysts (day 5 or 6) for embryo transfer.
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 |
|---|---|---|
| personalized Embryo Transfer (pET) | Other | Personalized embryo transfer (pET) |
| Frozen Embryo Transfer (FET) | Other | Frozen embryo transfer (FET) |
| Fresh Embryo Transfer (ET) | Other | Fresh embryo transfer (ET) |
Primary outcome
Live birth delivery rate
Time frame: 40 weeks
Percentage of deliveries that resulted in at least one live birth per embryo transfer.
8 secondary outcomes
Implantation rate
Time frame: 12 weeks
Pregnancy rate
Time frame: 20 weeks
Biochemical pregnancies
Time frame: 20 weeks
Ectopic pregnancies
Time frame: 20 weeks
Clinical miscarriages
Time frame: 20 weeks
Cumulative pregnancy rate
Time frame: 12 months
Cumulative implantation rate
Time frame: 12 months
Cumulative live birth delivery rate
Time frame: 12 months
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 Feb 2019.
- Derived from this study: PubMed 27365540Katzorke N, Vilella F, Ruiz M, Krussel JS, Simon C. Diagnosis of Endometrial-Factor Infertility: Current Approaches and New Avenues for Research. Geburtshilfe Frauenheilkd. 2016 Jun;76(6):699-703. doi: 10.1055/s-0042-103752.
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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.
Carlos Simon, MDPhD principal investigator
IVI Valencia / Igenomix
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized Embryo Transfer (pET), Frozen Embryo Transfer (FET) and Fresh Embryo Transfer (ET) in people with Endometrial Receptivity, run by Igenomix at 16 sites in 7 countries.
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 8 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 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain, Brazil, Belgium, Bulgaria, Japan and 2 more countries. 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?
Live birth delivery rate (time frame: 40 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 NCT01954758, which also lists 1 linked publication.
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 Feb 2019.