Recurrent Implantation FailureERANCT07767240
ERA in Young Primary Infertile RIF Patients
An observational study of Recurrent Implantation Failure, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.
Trial summary
This study aims to evaluate the clinical efficacy of transcriptome-based endometrial receptivity analysis (tb-ERA) and investigate the molecular mechanisms of abnormal receptivity in young women with unexplained recurrent implantation failure (RIF). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Recurrent Implantation Failure
- What is being tested?
- tb-ERA and personalized embryo transfer
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 31 Dec 2027
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: This study will enroll women aged ≤ 35 years with a BMI of 18-25 kg/m². The RIF cohort includes patients with primary infertility and ≥ 3 failed transfers of high-quality embryos, further divided into the RIF-ERA group and the RIF non-ERA group (active comparator). The control group consists of patients undergoing their first IVF-ET cycle for tubal factor infertility, with no history of biochemical pregnancy or miscarriage. Patients with known causes of implantation failure will be excluded from all groups. All participants will provide written informed consent.
- RIF Cohort - Inclusion Criteria
- Age ≤ 35 years; BMI 18-25 kg/m².
- ≥ 3 failed transfers of high-quality embryos.
- No history of spontaneous or FET-related pregnancy, including biochemical pregnancy (primary infertility).
- Written informed consent provided.
- RIF Cohort - Exclusion Criteria
- Known factors associated with RIF, including: uterine anatomical abnormalities (malformations, adhesions, polyps, submucosal fibroids, adenomyosis) and hydrosalpinx
- Endocrine disorders (PCOS, thyroid dysfunction, hyperprolactinemia)
- Reproductive immunological abnormalities, thrombophilia and infectious factors, abnormal semen parameters,
- Chromosomal abnormalities in either partner (planned PGT-SR) or monogenic disease (planned PGT-M).
- Severe medical/surgical conditions contraindicating pregnancy.
- Any other condition deemed unsuitable by the investigators.
- Control Group - Inclusion Criteria
- Age ≤ 35 years; BMI 18-25 kg/m².
- First IVF-ET cycle due to tubal factor infertility.
- No history of biochemical pregnancy or miscarriage.
- Written informed consent provided.
- Control Group - Exclusion Criteria 1. Same as RIF Cohort Exclusion Criteria. Additionally, participants with an abnormal ERA result will be excluded from the control group.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lu Li, M.Sc. contact
China1 site
Shanghai Ji Ai Genetics and IVF Institute, Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, 200011
About this study
Official title: A Cohort Study of Endometrial Receptivity Analysis in Young, Primary Infertile Patients With Unexplained Recurrent Implantation Failure
This study aims to evaluate the clinical efficacy of transcriptome-based endometrial receptivity analysis (tb-ERA) and investigate the molecular mechanisms of abnormal receptivity in young women with unexplained recurrent implantation failure (RIF).
Read the detailed description
Young women with recurrent implantation failure (RIF) will be prospectively recruited and classified based on their Window of Implantation (WOI) status. Clinical outcomes will be compared between patients undergoing personalized embryo transfer (pET) and those receiving standard transfer. Concurrently, endometrial tissues collected at P+3 and P+5 will undergo RNA sequencing to elucidate the molecular mechanisms underlying abnormal receptivity. Integrating these clinical and transcriptomic data, we aim to develop a clinical prediction model for displaced WOI and validate the efficacy of pET in improving pregnancy outcomes for this specific population.
- Conditions
- Recurrent Implantation Failure
- Being tested
- tb-ERA and personalized embryo transfer
- Keywords
- endometrial receptivity analysis, recurrent implantation failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tb-ERA and personalized embryo transferOther
tb-ERA and personalized embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| ERA cohort | RIF patients with tb-ERA and personalized embryo transfer Receives: Other: tb-ERA and personalized embryo transfer | |
| Active Comparator | RIF patients receiving standard transfer | |
| Control | Non-RIF patients, receiving the first-time embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy
Ongoing pregnancy is defined as viable pregnancy beyond 12 weeks' gestation.
Measured: 12 weeks after embryo transfer
Secondary outcomes (2)
Clinical pregnancy
Pregnancy with ultrasound-confirmed intrauterine gestational sac(s)
Measured: 6 to 8 weeks after embryo transfer
Implantation rate
The proportion of gestational sacs observed divided by the total number of embryos transferred
Measured: 6 to 8 weeks 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 posted17 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Recurrent 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lu Li, M.Sc., Principal investigator, Shanghai Ji Ai Genetics and IVF Institute, Obstetrics and Gynecology Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767240
- Sponsor's protocol ID
- JIAI E2025-01
- Acronym
- ERA
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data will be shared upon reasonable request to the corresponding author, subject to approval by the principal investigator and a signed data use agreement, following publication of the primary results. Data will be retained for a minimum of 5 years.
Publications
Cao D, Liu Y, Cheng Y, Wang J, Zhang B, Zhai Y, Zhu K, Liu Y, Shang Y, Xiao X, Chang Y, Lee YL, Yeung WSB, Huang Y, Yao Y. Time-series single-cell transcriptomic profiling of luteal-phase endometrium uncovers dynamic characteristics and its dysregulation in recurrent implantation failures. Nat Commun. 2025 Jan 2;16(1):137. doi: 10.1038/s41467-024-55419-z.
PubMed 39747825Cimadomo D, Rienzi L, Conforti A, Forman E, Canosa S, Innocenti F, Poli M, Hynes J, Gemmell L, Vaiarelli A, Alviggi C, Ubaldi FM, Capalbo A. Opening the black box: why do euploid blastocysts fail to implant? A systematic review and meta-analysis. Hum Reprod Update. 2023 Sep 5;29(5):570-633. doi: 10.1093/humupd/dmad010.
PubMed 37192834Busnelli A, Reschini M, Cardellicchio L, Vegetti W, Somigliana E, Vercellini P. How common is real repeated implantation failure? An indirect estimate of the prevalence. Reprod Biomed Online. 2020 Jan;40(1):91-97. doi: 10.1016/j.rbmo.2019.10.014. Epub 2019 Oct 29.
PubMed 31924493Glujovsky D, Lattes K, Miguens M, Pesce R, Ciapponi A. Personalized embryo transfer guided by endometrial receptivity analysis: a systematic review with meta-analysis. Hum Reprod. 2023 Jul 5;38(7):1305-1317. doi: 10.1093/humrep/dead098.
PubMed 37203432Zhang WB, Li J, Li Q, Lu X, Chen JL, Li L, Chen H, Fu W, Chen JC, Lu BJ, Wu H, Sun XX. Endometrial transcriptome profiling of patients with recurrent implantation failure during hormone replacement therapy cycles. Front Endocrinol (Lausanne). 2024 Jan 30;14:1292723. doi: 10.3389/fendo.2023.1292723. eCollection 2023.
PubMed 38352249
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Endometrial Receptivity Analysis in Young, Primary Infertile Patients With Unexplained Recurrent Implantation Failure
- ClinicalTrials.gov ID
- NCT07767240
- Acronym / sponsor ID
- ERA / JIAI E2025-01
- Conditions
- Recurrent Implantation Failure
- Keywords
- endometrial receptivity analysis, recurrent implantation failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF InstituteUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Aug 2026 (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.
This study aims to evaluate the clinical efficacy of transcriptome-based endometrial receptivity analysis (tb-ERA) and investigate the molecular mechanisms of abnormal receptivity in young women with unexplained recurrent implantation failure (RIF).
Detailed description
Young women with recurrent implantation failure (RIF) will be prospectively recruited and classified based on their Window of Implantation (WOI) status. Clinical outcomes will be compared between patients undergoing personalized embryo transfer (pET) and those receiving standard transfer. Concurrently, endometrial tissues collected at P+3 and P+5 will undergo RNA sequencing to elucidate the molecular mechanisms underlying abnormal receptivity. Integrating these clinical and transcriptomic data, we aim to develop a clinical prediction model for displaced WOI and validate the efficacy of pET in improving pregnancy outcomes for this specific population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ERA cohort | – | Other: tb-ERA and personalized embryo transferRIF patients with tb-ERA and personalized embryo transfer |
| Active Comparator | – | –RIF patients receiving standard transfer |
| Control | – | –Non-RIF patients, receiving the first-time embryo transfer |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will enroll women aged ≤ 35 years with a BMI of 18-25 kg/m². The RIF cohort includes patients with primary infertility and ≥ 3 failed transfers of high-quality embryos, further divided into the RIF-ERA group and the RIF non-ERA group (active comparator). The control group consists of patients undergoing their first IVF-ET cycle for tubal factor infertility, with no history of biochemical pregnancy or miscarriage. Patients with known causes of implantation failure will be excluded from all groups. All participants will provide written informed consent.
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 |
|---|---|---|
| tb-ERA and personalized embryo transfertb-ERA and personalized embryo transfer | Other | ERA cohort |
Primary outcome
Ongoing pregnancy
Time frame: 12 weeks after embryo transfer
Ongoing pregnancy is defined as viable pregnancy beyond 12 weeks' gestation.
2 secondary outcomes
Clinical pregnancy
Time frame: 6 to 8 weeks after embryo transfer
Implantation rate
Time frame: 6 to 8 weeks after embryo transfer
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 17 Aug 2026.
- Background: PubMed 39747825Cao D, Liu Y, Cheng Y, Wang J, Zhang B, Zhai Y, Zhu K, Liu Y, Shang Y, Xiao X, Chang Y, Lee YL, Yeung WSB, Huang Y, Yao Y. Time-series single-cell transcriptomic profiling of luteal-phase endometrium uncovers dynamic characteristics and its dysregulation in recurrent implantation failures. Nat Commun. 2025 Jan 2;16(1):137. doi: 10.1038/s41467-024-55419-z.
- Background: PubMed 37192834Cimadomo D, Rienzi L, Conforti A, Forman E, Canosa S, Innocenti F, Poli M, Hynes J, Gemmell L, Vaiarelli A, Alviggi C, Ubaldi FM, Capalbo A. Opening the black box: why do euploid blastocysts fail to implant? A systematic review and meta-analysis. Hum Reprod Update. 2023 Sep 5;29(5):570-633. doi: 10.1093/humupd/dmad010.
- Background: PubMed 31924493Busnelli A, Reschini M, Cardellicchio L, Vegetti W, Somigliana E, Vercellini P. How common is real repeated implantation failure? An indirect estimate of the prevalence. Reprod Biomed Online. 2020 Jan;40(1):91-97. doi: 10.1016/j.rbmo.2019.10.014. Epub 2019 Oct 29.
- Background: PubMed 37203432Glujovsky D, Lattes K, Miguens M, Pesce R, Ciapponi A. Personalized embryo transfer guided by endometrial receptivity analysis: a systematic review with meta-analysis. Hum Reprod. 2023 Jul 5;38(7):1305-1317. doi: 10.1093/humrep/dead098.
- Background: PubMed 38352249Zhang WB, Li J, Li Q, Lu X, Chen JL, Li L, Chen H, Fu W, Chen JC, Lu BJ, Wu H, Sun XX. Endometrial transcriptome profiling of patients with recurrent implantation failure during hormone replacement therapy cycles. Front Endocrinol (Lausanne). 2024 Jan 30;14:1292723. doi: 10.3389/fendo.2023.1292723. eCollection 2023.
- Individual participant dataSharing planned: Yes. De-identified individual patient data will be shared upon reasonable request to the corresponding author, subject to approval by the principal investigator and a signed data use agreement, following publication of the primary results. Data will be retained for a minimum of 5 years.
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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.
Lu Li, M.Sc. contact
Lu Li, M.Sc. principal investigator
Shanghai Ji Ai Genetics and IVF Institute, Obstetrics and Gynecology Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Implantation Failure, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 17 Aug 2026. 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 China. 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?
Contact Yilun Sui, M.D. (86-21-63459977, 965845006@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy (time frame: 12 weeks after embryo transfer). 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 NCT07767240, which also lists 5 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 17 Aug 2026.