Endometrial ReceptivityNCT04497558
The Clinical Efficiency of Tb-ERA in Chinese RIF Patients
A study testing Endometrium biopsy in people with Endometrial Receptivity and Repeated Implantation Failure, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.
Trial summary
In order to further explore the clinical utility of endometrial receptivity array in patients with repeated implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo endometrial receptivity array. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Endometrial Receptivity, Repeated Implantation Failure
- What is being tested?
- Endometrium biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2020to 30 Dec 2024
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- People with unexplained repeated implantation failure (3 or more times of transplantation, at least 4 or more high-quality embryos failed to conceive).
- Age: 20-40 years old.
- BMI: 19 - 24.
- The thickness of endometrium is more than or equal to 7 mm.
Who cannot join
- Known causes of embryo implantation failure, such as infection, reproductive tract malformation, uterine cavity factors, immune factors, hydrosalpinx, etc.
- Decreased ovarian function (meet the following at least two criteria: ① 10u / L < basal follicle stimulating hormone (FSH) < 25U / L, and / or estradiol (E2) > 292.8pmol/l, and / or FSH / LH > 3; ② the number of antral follicles < 5-7 on the second to third day of menstruation; and (or) antimullerian hormone (AMH) < 0.5-1.1ng/ml.
- People with genetic history.
- Those who have done abortion and the histogenetic analysis are positive.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
About this study
Official title: The Clinical Efficiency of Transcriptome-based Endometrial Receptivity Assessment (Tb-ERA) in Chinese Patients With Recurrent Implantation Failure (RIF)
In order to further explore the clinical utility of endometrial receptivity array in patients with repeated implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. Statistical analysis of the two groups of primary endpoint and secondary endpoint are done.
Read the detailed description
In the field of assisted reproduction techonology, there are still 10% of patients with repeated implantation failure. In order to further explore the clinical utility of endometrial receptivity array in patients with repeated implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. In the control group, no intervention will be performed. Statistical analysis of the two groups of primary endpoint (clinical pregnancy rate) and secondary endpoint (endometrial implantation window evaluation results, embryo implantation rate, biochemical pregnancy rate, early abortion rate, ectopic pregnancy rate) are done. Through the comparative analysis of clinical outcomes to verify the clinical efficacy of endometrial receptivity analysis in patients with repeated implant failure, this method will provide a new treatment for repeated implant failure population.
- Being tested
- Endometrium biopsy
- Keywords
- endometrial receptivity array, Repeated implantation failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrium biopsyDiagnostic test
In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. In the control group, no intervention will be performed.
| Study group | Role | What they receive |
|---|---|---|
| ERA group | Experimental | In the experimental group, those patients undergo endometrial receptivity array. According to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. Receives: Diagnostic Test: Endometrium biopsy |
| Control group | No intervention | In the control group, those patients do not receive any treatment before next cycle of transfer. In the control group, no intervention will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Clinical pregnancy rate in patients
Measured: 6 months
Secondary outcomes (5)
Endometrial implantation window evaluation results
Endometrial implantation window evaluation results in tested patients
Measured: 6 months
Embryo implantation rate
Embryo implantation rate in patients
Measured: 6 months
Biochemical pregnancy rate
Biochemical pregnancy rate in patients
Measured: 6 months
Early abortion rate
Early abortion rate in patients
Measured: 6 months
Ectopic pregnancy rate
Ectopic pregnancy rate in patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start20 Nov 2020
- Primary completion30 Dec 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbi Zhang, ShangHai Ji Ai Genetics & IVF Institute
- Investigators
- Xiaoxi Sun, Study chair, Obstetrics and Gynecology Hospital affiliated to Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497558
- Sponsor's protocol ID
- JIAI 2020-07
- Status last verified
- Feb 2025
- First submitted
- 28 Jul 2020
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruiz-Alonso M, Blesa D, Diaz-Gimeno P, Gomez E, Fernandez-Sanchez M, Carranza F, Carrera J, Vilella F, Pellicer A, Simon C. The endometrial receptivity array for diagnosis and personalized embryo transfer as a treatment for patients with repeated implantation failure. Fertil Steril. 2013 Sep;100(3):818-24. doi: 10.1016/j.fertnstert.2013.05.004. Epub 2013 Jun 4.
PubMed 23756099Hashimoto T, Koizumi M, Doshida M, Toya M, Sagara E, Oka N, Nakajo Y, Aono N, Igarashi H, Kyono K. Efficacy of the endometrial receptivity array for repeated implantation failure in Japan: A retrospective, two-centers study. Reprod Med Biol. 2017 Jun 27;16(3):290-296. doi: 10.1002/rmb2.12041. eCollection 2017 Jul.
PubMed 29259480Zhang WB, Li H, Lu X, Chen JL, Li L, Chen JC, Wu H, Sun XX. The clinical efficiency of transcriptome-based endometrial receptivity assessment (Tb-ERA) in Chinese patients with recurrent implantation failure (RIF): A study protocol for a prospective randomized controlled trial. Contemp Clin Trials Commun. 2022 May 28;28:100928. doi: 10.1016/j.conctc.2022.100928. eCollection 2022 Aug.
PubMed 35669489
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficiency of Transcriptome-based Endometrial Receptivity Assessment (Tb-ERA) in Chinese Patients With Recurrent Implantation Failure (RIF)
- ClinicalTrials.gov ID
- NCT04497558
- Acronym / sponsor ID
- JIAI 2020-07
- Keywords
- endometrial receptivity array, Repeated implantation failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF InstituteUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 4 Aug 2020 (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.
In order to further explore the clinical utility of endometrial receptivity array in patients with repeated implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. Statistical analysis of the two groups of primary endpoint and secondary endpoint are done.
Detailed description
In the field of assisted reproduction techonology, there are still 10% of patients with repeated implantation failure. In order to further explore the clinical utility of endometrial receptivity array in patients with repeated implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. In the control group, no intervention will be performed. Statistical analysis of the two groups of primary endpoint (clinical pregnancy rate) and secondary endpoint (endometrial implantation window evaluation results, embryo implantation rate, biochemical pregnancy rate, early abortion rate, ectopic pregnancy rate) are done. Through the comparative analysis of clinical outcomes to verify the clinical efficacy of endometrial receptivity analysis in patients with repeated implant failure, this method will provide a new treatment for repeated implant failure population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERA group | Experimental | Diagnostic Test: Endometrium biopsyIn the experimental group, those patients undergo endometrial receptivity array. According to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. |
| Control group | No intervention | –In the control group, those patients do not receive any treatment before next cycle of transfer. In the control group, no intervention will be performed. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- People with unexplained repeated implantation failure (3 or more times of transplantation, at least 4 or more high-quality embryos failed to conceive).
- Age: 20-40 years old.
- BMI: 19 - 24.
- The thickness of endometrium is more than or equal to 7 mm.
Key exclusion criteria (4 listed)
- Known causes of embryo implantation failure, such as infection, reproductive tract malformation, uterine cavity factors, immune factors, hydrosalpinx, etc.
- Decreased ovarian function (meet the following at least two criteria: ① 10u / L < basal follicle stimulating hormone (FSH) < 25U / L, and / or estradiol (E2) > 292.8pmol/l, and / or FSH / LH > 3; ② the number of antral follicles < 5-7 on the second to third day of menstruation; and (or) antimullerian hormone (AMH) < 0.5-1.1ng/ml.
- People with genetic history.
- Those who have done abortion and the histogenetic analysis are positive.
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 |
|---|---|---|
| Endometrium biopsyIn the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. In the control group, no intervention will be performed. | Diagnostic test | ERA group |
Primary outcome
Clinical pregnancy rate
Time frame: 6 months
Clinical pregnancy rate in patients
5 secondary outcomes
Endometrial implantation window evaluation results
Time frame: 6 months
Embryo implantation rate
Time frame: 6 months
Biochemical pregnancy rate
Time frame: 6 months
Early abortion rate
Time frame: 6 months
Ectopic pregnancy rate
Time frame: 6 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 26 Feb 2025.
- Background: PubMed 23756099Ruiz-Alonso M, Blesa D, Diaz-Gimeno P, Gomez E, Fernandez-Sanchez M, Carranza F, Carrera J, Vilella F, Pellicer A, Simon C. The endometrial receptivity array for diagnosis and personalized embryo transfer as a treatment for patients with repeated implantation failure. Fertil Steril. 2013 Sep;100(3):818-24. doi: 10.1016/j.fertnstert.2013.05.004. Epub 2013 Jun 4.
- Background: PubMed 29259480Hashimoto T, Koizumi M, Doshida M, Toya M, Sagara E, Oka N, Nakajo Y, Aono N, Igarashi H, Kyono K. Efficacy of the endometrial receptivity array for repeated implantation failure in Japan: A retrospective, two-centers study. Reprod Med Biol. 2017 Jun 27;16(3):290-296. doi: 10.1002/rmb2.12041. eCollection 2017 Jul.
- Derived from this study: PubMed 35669489Zhang WB, Li H, Lu X, Chen JL, Li L, Chen JC, Wu H, Sun XX. The clinical efficiency of transcriptome-based endometrial receptivity assessment (Tb-ERA) in Chinese patients with recurrent implantation failure (RIF): A study protocol for a prospective randomized controlled trial. Contemp Clin Trials Commun. 2022 May 28;28:100928. doi: 10.1016/j.conctc.2022.100928. eCollection 2022 Aug.
- 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.
Xiaoxi Sun study chair
Obstetrics and Gynecology Hospital affiliated to Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrium biopsy in people with Endometrial Receptivity and Repeated 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?
The sponsor lists 4 inclusion and 4 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 26 Feb 2025. 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?
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?
Clinical pregnancy rate (time frame: 6 months). 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 NCT04497558, which also lists 3 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 26 Feb 2025.