Infertility of Uterine OriginNCT06097559
International Non-selection Study for ERA® Test in Patients With Previous Implantation Failures
An observational study of Infertility of Uterine Origin and Implantation Failure, run by Igenomix at 8 sites in 4 countries.
Trial summary
Women´s period comprises different hormonal stages, being one of them the stage for maximum receptivity and proper embryo implantation. This stage is named window of implantation (WOI), and is characterized by a specific molecular pattern than can be assessed by the Endometrial Receptivity Analysis (ERA® test)… Read more about this study
- Who is it for?
- Ages 18 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility of Uterine Origin, Implantation Failure
- What is being tested?
- Endometrial fluid and biopsy collection
- How many people
- 738 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 16 Jan 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 41 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Infertile women scheduled for an in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycle with one or more previous failed euploid/low-range mosaic embryo transfer(s) or with two or more previous failed transfers with non-tested good quality embryos, who will receive a transfer of a frozen euploid/low-range mosaic blastocyst (day 5/6) in an HRT cycle.
Who may be able to join
- Study ICF signature.
- Female age between 18 and 41 years (both included).
- IVF/ICSI (own or donated gametes) patients with ≥1 previous failed euploid/low-range mosaic embryo transfer(s) or ≥2 previous failed transfers with non-tested good quality embryos. (ROPA method is allowed).
- ≥1 PGT-A tested euploid/low-range mosaic blastocyst (day 5/6) available to be transferred (SET or DET according to medical recommendation).
- BMI 18.0 - 30.0 Kg/m2.
- Negative serological tests for HIV, HBV, HCV, RPR.
Who cannot join
- No HRT in the biopsy and/or the embryo transfer cycle.
- Intrauterine device (IUD) carriers within 3 months before sample collection.
- Surrogate pregnancy (in those countries where it is allowed).
- Adenomyosis or any pathological finding affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas > 4 cm, or hydrosalpinx. (Note: Patients are allowed to participate if the pathology is previously operated at least 3 months before the endometrial samples are obtained).
- Recurrent Pregnancy Loss (RPL ≥2 previous intrauterine miscarriages).
- Active endometritis and salpingitis at the moment of the inclusion.
Show all 12Show fewer
- Endometriosis stage > I (stages II, III and IV) according to ASRM classification.
- Atrophic endometrium (< 6 mm) in the ERA® and/or embryo transfer cycle.
- Endometrial receptivity test and/or microbiome test done before ICF signature.
- Preimplantation Genetic Testing for Chromosomal Structural Rearrangements (PGT-SR) or Preimplantation Genetic Testing for Monogenic Disorders (PGT-M) concomitant indications.
- DuoStim IVF protocol (double ovarian stimulation and two egg retrievals in the same ovarian cycle).
- Any illness or medical condition that is unstable or which, according to medical criteria, may put at risk the patient's safety and her compliance in the study.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Spain5 sites
Ovoclinic Madrid
Madrid, Madrid, 28035
URE Centro Gutenberg
Málaga, Málaga, 29016
Ovoclinic Marbella
Marbella, Málaga, 29603
Vida Recoletas Sevilla
Seville, Sevilla, 41092
Vida Recoletas Valladolid
Valladolid, 47004
About this study
Official title: A Multicenter, Prospective, Non-selection Study for Endometrial Receptivity Analysis Test in Patients With Previous Implantation Failures
Women´s period comprises different hormonal stages, being one of them the stage for maximum receptivity and proper embryo implantation. This stage is named window of implantation (WOI), and is characterized by a specific molecular pattern than can be assessed by the Endometrial Receptivity Analysis (ERA® test), developed by Igenomix. Determining the WOI allows to schedule a personalized embryo transfer (pET) when the endometrium is most receptive for the implantation.
The main objective of the present study is to improve our knowledge on the endometrial factor in an infertile population with previous implantation failures. To do so, a diagnosis of the endometrial receptivity to determine the WOI (ERA®) and the microbiome (EMMA®) of each participant will be performed, assessing its impact on deferred embryo transfers in terms of reproductive outcomes.
Participants will follow their previously programmed IVF/ICSI treatment and, only when one embryo with no major anomalies is reported by PGT-A (Preimplantation Genetic Testing for Aneuploidies), they will be asked to attend to the specific study visit for endometrial fluid and biopsy samples collection. These samples will be used to determine the patient's WOI (ERA®) and endometrial microbiome (EMMA®). The results of neither of the tests will be disclosed to the patient or the doctor, being only used for the study purpose. After this visit, the patient will follow the pre-established schedule for an embryo transfer and pregnancy assessment.
Read the detailed description
Endometrial receptivity takes place in a self-limited period of time during the endometrial mid-secretory stage. This period, named as window of implantation (WOI), is modulated by molecular changes allowing embryo implantation. The Igenomix group developed a molecular tool able to classify the endometrium based on its transcriptomic profile, the Endometrial Receptivity Analysis (ERA®). This molecular tool analyzes, by next generation sequencing (NGS), the expression of 248 genes related to implantation, coupled to a computational predictor, to identify the specific transcriptomic profile for each endometrial phase. This test has been applied clinically since 2010 to improve clinical implantation, helping to synchronize a viable embryo with a receptive endometrium through the personalized embryo transfer (pET).
Apart from receptivity, there are other approaches to study the impact of the endometrial factor in infertility. One of those is the analysis of the endometrial microbiome (set of microorganisms that live in the endometrium). A reduced presence of certain beneficial microorganisms (mostly, bacteria of the genus Lactobacillus) or even the presence of a pathogenic microbiota in the endometrium could be associated with worse reproductive outcomes, affecting embryo implantation, pregnancy and consequently reducing the number of births. Igenomix has also developed the Endometrial Microbiome Metagenomic Analysis (EMMA®) as a diagnostic method to assess the microbiome content of the endometrium. Both, ERA® and EMMA® analyses, can be performed with a single endometrial tissue sample collected when maximum receptivity is commonly expected.
The main questions this study aims to answer are:
- If a pET in a specific receptive endometrial transcriptomic profile is related to a higher Ongoing Pregnancy Rate (OPR) (≥ 12 gestational weeks; fetal heartbeat diagnosis) in patients with at least one previous implantation failure. This may help to fine-tune the ERA computational analysis for some specific endometrial receptivity profiles.
- To identify new potential biomarkers and other factors that, if related with the WOI, could help to predict an optimal embryo implantation.
Once the study is approved by the competent Research Ethics Committee of each center, the recruitment and selection of patients will follow. Every potential participant will be asked to sign the study informed consent. To comply with the study design and the proposed hypothesis, a total number of 738 patients has been estimated, considering a 30% dropout rate.
This is a multicenter, international, competitive, non-selection (prospective cohort) study designed with two phases:
- Non-selection phase (double-blinded design). Participants will follow their previously programmed IVF/ICSI treatment and the resulting embryo/s will be tested for chromosomic anomalies with the Preimplantation Genetic Testing for Aneuploidies (PGT-A) at Igenomix. When at least one euploid/low-range mosaic blastocyst is reported, the patient will be scheduled for the only additional visit related to the study to collect the endometrial fluid and biopsy samples that will be used to determine the patient's WOI (ERA®) and endometrial microbiome (EMMA®). The results of neither of the tests will be disclosed to the patient or the doctor. Therefore, regardless of the endometrial status, the patient will follow the pre-established schedule for a subsequent regular frozen embryo transfer (FET) within the standard WOI (after 120±6 hours of progesterone exposure) in a hormone replacement therapy (HRT) cycle. After the FET, participants will be followed up as routine by their gynecologist.
- Rescue phase (open design). The ERA® test result may be disclosed, under request, to those patients who did not achieve an ongoing pregnancy on the non-selection phase. These results could guide a subsequent personalized euploid/low-range mosaic blastocyst transfer (pET) in a new HRT cycle, when the patient is most receptive.
Data exported from the medical records and source documents will be duly codified to protect the clinical and personal information of patients in accordance with the current legislation on data protection. This information will be exported to an electronic Case Report Form (eCRF). An interim data analysis will be carried out once the 30% of the embryo transfers corresponding to the non-selection phase is achieved. It will help us to assess the enrollment rate, protocol compliance and an early evaluation of the study objectives.
Patient´s participation will comprise an estimated total time of up to 18 months, corresponding to 1 month for the stimulation cycle and PGT-A, 1-2 months for endometrial samples collection, 1-2 months for the embryo transfer and up to 13 months to follow-up the clinical outcomes.
- Being tested
- Endometrial fluid and biopsy collection
- Keywords
- Infertility, Implantation failure, Uterine microbiome, Preimplantational Genetic Testing for Aneuploidies, Endometrial factor, Window of implantation, Endometrial receptivity, Personalized embryo transfer, Frozen embryo transfer, Endometrial Receptivity Analysis (ERA)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial fluid and biopsy collectionDiagnostic test
The ERA and EMMA test require an endometrial biopsy to be taken at P+5 (after 120±6 hours of exogenous progesterone administration) in a HRT cycle, according to the common clinical practice. On the same day, a sample of endometrial fluid will be aspirated immediately prior to the biopsy.
Regardless of the endometrial receptivity profile, a subsequent regular FET will be performed within the standard WOI (after 120±6 hours of progesterone exposure) in an HRT cycle following the clinical standard practice.
Those patients willing to participate in the rescue phase will follow the recommendation of the ERA test for the subsequent pET.
Endometrial fluid and biopsy collectionDiagnostic test
The ERA and EMMA test require an endometrial biopsy to be taken at P+5 (after 120±6 hours of exogenous progesterone administration), according to the common clinical practice. On the same day, a sample of endometrial fluid will be aspirated immediately prior to the biopsy.
Regardless of the endometrial receptivity profile, a subsequent regular FET will be performed within the standard WOI (after 120±6 hours of progesterone exposure) in an HRT cycle following the clinical standard practice.
Those patients willing to participate in the rescue phase will follow the recommendation of the ERA test for the subsequent pET. In case of a non-receptive endometrium result, a second EB sample must be collected when indicated by the ERA report. Fluid sample collection will not be repeated in these cases.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Outcomes in a Receptive Endometrium | Enrolled patients that according to the ERA® report are receptive.
The only additional intervention that patients will undergo, apart from those already scheduled for their ART, is the collection of an endometrial biopsy and endometrial fluid.
No drugs will be administered as per the study. Receives: Diagnostic Test: Endometrial fluid and biopsy collection | |
| Clinical Outcomes in a Non-receptive Endometrium | Enrolled patients that according to the ERA® report have a displaced WOI and are non-receptive.
The only additional intervention that patients will undergo, apart from those already scheduled for their ART, is the collection of an endometrial biopsy and endometrial fluid.
No drugs will be administered as per the study. Receives: Diagnostic Test: Endometrial fluid and biopsy collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refinement of the ERA® computational analysis
Comparison of the OPR (≥ 12 gestational weeks; fetal heartbeat diagnosis) in patients with receptive endometrium vs displaced WOI in the 1st FET.
Measured: At least 12 gestational weeks
Secondary outcomes (18)
Pregnancy rate (PR) in the FET
Number of patients with positive serum level of β-human chorionic gonadotropin (βhCG > 25 mIU/ml) per embryo transfer. Beta-hCG will be measured at day 12±2 after the embryo transfer.
Measured: 2 weeks after the embryo transfer
Implantation rate (IR) in the FET
Number of gestational sacs observed by vaginal ultrasound divided by the number of embryos transferred.
Measured: Up to 4 weeks after the embryo transfer
Biochemical pregnancy rate (BPR) in the FET
Number of pregnancies diagnosed only by β-hCG detection without a gestational sac visualized by vaginal ultrasound, per number of pregnancies.
Measured: 4 weeks after the embryo transfer
Ectopic pregnancy rate (EPR) in the FET
Number of pregnancies outside the uterine cavity, diagnosed clinically, hormonally, by ultrasound, surgical visualization or histopathology, per number of pregnancies.
Measured: 4-5 weeks after the embryo transfer
Clinical miscarriage rate (CMR) in the FET
Number of spontaneous pregnancy losses before week 22, in which a gestational sac/s was previously observed, per number of pregnancies.
Measured: Up to 22 gestational weeks
Ongoing Pregnancy Rate (OPR) in the FET
Number of pregnancies up to 12 gestational weeks (at least one fetus with a discernible heartbeat diagnosed) achieved per each embryo transfer.
Measured: Over 12 gestational weeks
Live Birth Delivery Rate (LBDR) in the FET
Number of deliveries that resulted in at least one live birth per embryo transfer. Live birth is defined as the complete expulsion or extraction from a woman of a product of conception after 22 weeks of gestation, which, after such separation, breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached.
Measured: 40 gestational weeks
Pregnancy rate (PR) in the pET
Number of patients with positive serum level of β-human chorionic gonadotropin (βhCG > 25 mIU/ml) per embryo transfer. Beta-hCG will be measured at day 12±2 after the embryo transfer.
Measured: 2 weeks after the embryo transfer
Implantation rate (IR) in the pET
Number of gestational sacs observed by vaginal ultrasound divided by the number of embryos transferred.
Measured: Up to 4 weeks after the embryo transfer
Biochemical pregnancy rate (BPR) in the pET
Number of pregnancies diagnosed only by β-hCG detection without a gestational sac visualized by vaginal ultrasound, per number of pregnancies.
Measured: 4 weeks after the embryo transfer
Ectopic pregnancy rate (EPR) in the pET
Number of pregnancies outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology, per number of pregnancies.
Measured: 4-5 weeks after the embryo transfer
Clinical miscarriage rate (CMR) in the pET
Number of spontaneous pregnancy losses before week 22, in which a gestational sac/s was previously observed, per number of pregnancies.
Measured: Up to 22 gestational weeks
Ongoing Pregnancy Rate (OPR) in the pET
Number of pregnancies up to 12 gestational weeks (at least one fetus with a discernible heartbeat diagnosed) achieved per each embryo transfer.
Measured: Over 12 gestational weeks
Identification of new potential actionable biomarkers for endometrial receptivity
Associated genes potentially related with metabolic, inflammatory, and immunological pathways from mRNA ERA® samples.
Measured: 1-2 months
Clinical reproductive outcomes according to the microbiome profile by the EMMA® test
Analysis of the bacterial DNA by next generation sequencing and its possible influence in PR, IR, BPR, EPR, CMR, OPR and LBDR.
Measured: Up to 40 gestational weeks
Microbiome analysis concordance between endometrial fluid and biopsy
Comparison of the EMMA® test results with endometrial biopsy and endometrial fluid
Measured: 1-2 months
Determination of immune and metabolic changes related to endometrial receptivity
Finding of novel underlying mechanisms of impaired endometrium receptivity caused by immune and metabolic alterations
Measured: 1-2 months
Cost-effectiveness of OP per patient
Calculation of the cost of pregnancy achievement per patient
Measured: At least 12 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start16 Jan 2024
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility of Uterine OriginStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 738 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Ruiz, MSc, Principal investigator, Igenomix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097559
- Sponsor's protocol ID
- IGX1-ENS-MR-22-05
- Status last verified
- Jul 2025
- First submitted
- 18 Oct 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Non-selection Study for Endometrial Receptivity Analysis Test in Patients With Previous Implantation Failures
- ClinicalTrials.gov ID
- NCT06097559
- Acronym / sponsor ID
- IGX1-ENS-MR-22-05
- Keywords
- Infertility, Implantation failure, Uterine microbiome, Preimplantational Genetic Testing for Aneuploidies, Endometrial factor, Window of implantation, Endometrial receptivity, Personalized embryo transfer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 738 participants (estimated)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Oct 2023 (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.
Women´s period comprises different hormonal stages, being one of them the stage for maximum receptivity and proper embryo implantation. This stage is named window of implantation (WOI), and is characterized by a specific molecular pattern than can be assessed by the Endometrial Receptivity Analysis (ERA® test), developed by Igenomix. Determining the WOI allows to schedule a personalized embryo transfer (pET) when the endometrium is most receptive for the implantation.
The main objective of the present study is to improve our knowledge on the endometrial factor in an infertile population with previous implantation failures. To do so, a diagnosis of the endometrial receptivity to determine the WOI (ERA®) and the microbiome (EMMA®) of each participant will be performed, assessing its impact on deferred embryo transfers in terms of reproductive outcomes.
Participants will follow their previously programmed IVF/ICSI treatment and, only when one embryo with no major anomalies is reported by PGT-A (Preimplantation Genetic Testing for Aneuploidies), they will be asked to attend to the specific study visit for endometrial fluid and biopsy samples collection. These samples will be used to determine the patient's WOI (ERA®) and endometrial microbiome (EMMA®). The results of neither of the tests will be disclosed to the patient or the doctor, being only used for the study purpose. After this visit, the patient will follow the pre-established schedule for an embryo transfer and pregnancy assessment.
Detailed description
Endometrial receptivity takes place in a self-limited period of time during the endometrial mid-secretory stage. This period, named as window of implantation (WOI), is modulated by molecular changes allowing embryo implantation. The Igenomix group developed a molecular tool able to classify the endometrium based on its transcriptomic profile, the Endometrial Receptivity Analysis (ERA®). This molecular tool analyzes, by next generation sequencing (NGS), the expression of 248 genes related to implantation, coupled to a computational predictor, to identify the specific transcriptomic profile for each endometrial phase. This test has been applied clinically since 2010 to improve clinical implantation, helping to synchronize a viable embryo with a receptive endometrium through the personalized embryo transfer (pET).
Apart from receptivity, there are other approaches to study the impact of the endometrial factor in infertility. One of those is the analysis of the endometrial microbiome (set of microorganisms that live in the endometrium). A reduced presence of certain beneficial microorganisms (mostly, bacteria of the genus Lactobacillus) or even the presence of a pathogenic microbiota in the endometrium could be associated with worse reproductive outcomes, affecting embryo implantation, pregnancy and consequently reducing the number of births. Igenomix has also developed the Endometrial Microbiome Metagenomic Analysis (EMMA®) as a diagnostic method to assess the microbiome content of the endometrium. Both, ERA® and EMMA® analyses, can be performed with a single endometrial tissue sample collected when maximum receptivity is commonly expected.
The main questions this study aims to answer are:
- If a pET in a specific receptive endometrial transcriptomic profile is related to a higher Ongoing Pregnancy Rate (OPR) (≥ 12 gestational weeks; fetal heartbeat diagnosis) in patients with at least one previous implantation failure. This may help to fine-tune the ERA computational analysis for some specific endometrial receptivity profiles.
- To identify new potential biomarkers and other factors that, if related with the WOI, could help to predict an optimal embryo implantation.
Once the study is approved by the competent Research Ethics Committee of each center, the recruitment and selection of patients will follow. Every potential participant will be asked to sign the study informed consent. To comply with the study design and the proposed hypothesis, a total number of 738 patients has been estimated, considering a 30% dropout rate.
This is a multicenter, international, competitive, non-selection (prospective cohort) study designed with two phases:
- Non-selection phase (double-blinded design). Participants will follow their previously programmed IVF/ICSI treatment and the resulting embryo/s will be tested for chromosomic anomalies with the Preimplantation Genetic Testing for Aneuploidies (PGT-A) at Igenomix. When at least one euploid/low-range mosaic blastocyst is reported, the patient will be scheduled for the only additional visit related to the study to collect the endometrial fluid and biopsy samples that will be used to determine the patient's WOI (ERA®) and endometrial microbiome (EMMA®). The results of neither of the tests will be disclosed to the patient or the doctor. Therefore, regardless of the endometrial status, the patient will follow the pre-established schedule for a subsequent regular frozen embryo transfer (FET) within the standard WOI (after 120±6 hours of progesterone exposure) in a hormone replacement therapy (HRT) cycle. After the FET, participants will be followed up as routine by their gynecologist.
- Rescue phase (open design). The ERA® test result may be disclosed, under request, to those patients who did not achieve an ongoing pregnancy on the non-selection phase. These results could guide a subsequent personalized euploid/low-range mosaic blastocyst transfer (pET) in a new HRT cycle, when the patient is most receptive.
Data exported from the medical records and source documents will be duly codified to protect the clinical and personal information of patients in accordance with the current legislation on data protection. This information will be exported to an electronic Case Report Form (eCRF). An interim data analysis will be carried out once the 30% of the embryo transfers corresponding to the non-selection phase is achieved. It will help us to assess the enrollment rate, protocol compliance and an early evaluation of the study objectives.
Patient´s participation will comprise an estimated total time of up to 18 months, corresponding to 1 month for the stimulation cycle and PGT-A, 1-2 months for endometrial samples collection, 1-2 months for the embryo transfer and up to 13 months to follow-up the clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Outcomes in a Receptive Endometrium | – | Diagnostic Test: Endometrial fluid and biopsy collectionEnrolled patients that according to the ERA® report are receptive. The only additional intervention that patients will undergo, apart from those already scheduled for their ART, is the collection of an endometrial biopsy and endometrial fluid. No drugs will be administered as per the study. |
| Clinical Outcomes in a Non-receptive Endometrium | – | Diagnostic Test: Endometrial fluid and biopsy collectionEnrolled patients that according to the ERA® report have a displaced WOI and are non-receptive. The only additional intervention that patients will undergo, apart from those already scheduled for their ART, is the collection of an endometrial biopsy and endometrial fluid. No drugs will be administered as per the study. |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Infertile women scheduled for an in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycle with one or more previous failed euploid/low-range mosaic embryo transfer(s) or with two or more previous failed transfers with non-tested good quality embryos, who will receive a transfer of a frozen euploid/low-range mosaic blastocyst (day 5/6) in an HRT cycle.
Key inclusion criteria (6 listed)
- Study ICF signature.
- Female age between 18 and 41 years (both included).
- IVF/ICSI (own or donated gametes) patients with ≥1 previous failed euploid/low-range mosaic embryo transfer(s) or ≥2 previous failed transfers with non-tested good quality embryos. (ROPA method is allowed).
- ≥1 PGT-A tested euploid/low-range mosaic blastocyst (day 5/6) available to be transferred (SET or DET according to medical recommendation).
- BMI 18.0 - 30.0 Kg/m2.
Key exclusion criteria (12 listed)
- No HRT in the biopsy and/or the embryo transfer cycle.
- Intrauterine device (IUD) carriers within 3 months before sample collection.
- Surrogate pregnancy (in those countries where it is allowed).
- Adenomyosis or any pathological finding affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas > 4 cm, or hydrosalpinx. (Note: Patients are allowed to participate if the pathology is previously operated at least 3 months before the endometrial samples are obtained).
- Recurrent Pregnancy Loss (RPL ≥2 previous intrauterine miscarriages).
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 fluid and biopsy collectionThe ERA and EMMA test require an endometrial biopsy to be taken at P+5 (after 120±6 hours of exogenous progesterone administration) in a HRT cycle, according to the common clinical practice. On the same day, a sample of endometrial fluid will be aspirated immediately prior to the biopsy. Regardless of the endometrial receptivity profile, a subsequent regular FET will be performed within the standard WOI (after 120±6 hours of progesterone exposure) in an HRT cycle following the clinical standard practice. Those patients willing to participate in the rescue phase will follow the recommendation of the ERA test for the subsequent pET. | Diagnostic test | Clinical Outcomes in a Receptive Endometrium |
| Endometrial fluid and biopsy collectionThe ERA and EMMA test require an endometrial biopsy to be taken at P+5 (after 120±6 hours of exogenous progesterone administration), according to the common clinical practice. On the same day, a sample of endometrial fluid will be aspirated immediately prior to the biopsy. Regardless of the endometrial receptivity profile, a subsequent regular FET will be performed within the standard WOI (after 120±6 hours of progesterone exposure) in an HRT cycle following the clinical standard practice. Those patients willing to participate in the rescue phase will follow the recommendation of the ERA test for the subsequent pET. In case of a non-receptive endometrium result, a second EB sample must be collected when indicated by the ERA report. Fluid sample collection will not be repeated in these cases. | Diagnostic test | Clinical Outcomes in a Non-receptive Endometrium |
Primary outcome
Refinement of the ERA® computational analysis
Time frame: At least 12 gestational weeks
Comparison of the OPR (≥ 12 gestational weeks; fetal heartbeat diagnosis) in patients with receptive endometrium vs displaced WOI in the 1st FET.
18 secondary outcomes
Pregnancy rate (PR) in the FET
Time frame: 2 weeks after the embryo transfer
Implantation rate (IR) in the FET
Time frame: Up to 4 weeks after the embryo transfer
Biochemical pregnancy rate (BPR) in the FET
Time frame: 4 weeks after the embryo transfer
Ectopic pregnancy rate (EPR) in the FET
Time frame: 4-5 weeks after the embryo transfer
Clinical miscarriage rate (CMR) in the FET
Time frame: Up to 22 gestational weeks
Ongoing Pregnancy Rate (OPR) in the FET
Time frame: Over 12 gestational weeks
Live Birth Delivery Rate (LBDR) in the FET
Time frame: 40 gestational weeks
Pregnancy rate (PR) in the pET
Time frame: 2 weeks after the embryo transfer
Implantation rate (IR) in the pET
Time frame: Up to 4 weeks after the embryo transfer
Biochemical pregnancy rate (BPR) in the pET
Time frame: 4 weeks after the embryo transfer
Ectopic pregnancy rate (EPR) in the pET
Time frame: 4-5 weeks after the embryo transfer
Clinical miscarriage rate (CMR) in the pET
Time frame: Up to 22 gestational weeks
Ongoing Pregnancy Rate (OPR) in the pET
Time frame: Over 12 gestational weeks
Identification of new potential actionable biomarkers for endometrial receptivity
Time frame: 1-2 months
Clinical reproductive outcomes according to the microbiome profile by the EMMA® test
Time frame: Up to 40 gestational weeks
Microbiome analysis concordance between endometrial fluid and biopsy
Time frame: 1-2 months
Determination of immune and metabolic changes related to endometrial receptivity
Time frame: 1-2 months
Cost-effectiveness of OP per patient
Time frame: At least 12 gestational weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Maria Ruiz, MSc principal investigator
Igenomix
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility of Uterine Origin and Implantation Failure, run by Igenomix at 8 sites in 4 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 6 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Argentina, Panama, Peru. 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?
This study is still under way. Results are not available in the source record yet.
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?
Refinement of the ERA® computational analysis (time frame: At least 12 gestational weeks). 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 5 Aug 2025.