Recurrent Implantation FailureRIFNCT07363018
Efficacy of a Non-Invasive Endometrial Receptivity Prediction Model Based on Peripheral Blood miRNA Signatures During the Peri-Implantation Period in Improving IVF Outcomes in Patients With Unexplained RIF
A study testing Non-invasive endometrial receptivity prediction model guides personalized embryo transfer for patients with recurrent implantation failure (RIF). in people with Recurrent Implantation Failure, run by Tang-Du Hospital.
Trial summary
The goal of this clinical trial aims to investigate whether a non-invasive implantation window prediction model, constructed based on characteristic changes in peripheral blood miRNAs during the peri-implantation period, can improve pregnancy outcomes in patients with unexplained recurrent implantation failure… Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Recurrent Implantation Failure
- What is being tested?
- Non-invasive endometrial receptivity prediction model guides personalized embryo transfer for patients with recurrent implantation failure (RIF).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Sep 2027
- Phase
- Interventional
- 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 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with unexplained recurrent implantation failure (RIF) meeting the diagnostic criteria for RIF: adult women under 40 years old who have failed to achieve clinical pregnancy after 3 embryo transfer cycles; or after transferring at least 3 high-quality embryos.
- Definition of high-quality embryos: Day 3 embryos (with a cell count ≥7 and fragmentation rate <10%) and blastocysts (≥3BB).
- Female BMI: 18.5-25 kg/m².
- Endometrial thickness ≥7 mm during the embryo transfer cycle.
- Women planning to undergo frozen-thawed embryo transfer (FET) of blastocysts following in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
- Signed informed consent form.
Who cannot join
- Known causes of embryo implantation failure, such as infections, reproductive tract malformations, uterine cavity factors, adenomyosis or endometriosis, autoimmune system diseases (diagnosed by immunology department), hydrosalpinx, etc.
- Couples with chromosomal abnormalities (excluding chromosomal polymorphisms) or familial genetic disorders in either or both partners.
- Women with a history of recurrent miscarriage.
- Women with contraindications to pregnancy or assisted reproductive technology.
About this study
Official title: Efficacy of a Non-Invasive Endometrial Receptivity Prediction Model Based on Peripheral Blood miRNA Signatures During the Peri-Implantation Period in Improving IVF Outcomes in Patients With Unexplained Recurrent Implantation Failure: A Prospective, Single-Blind, Two-Arm, Parallel Randomized Controlled Trial
The goal of this clinical trial aims to investigate whether a non-invasive implantation window prediction model, constructed based on characteristic changes in peripheral blood miRNAs during the peri-implantation period, can improve pregnancy outcomes in patients with unexplained recurrent implantation failure undergoing frozen embryo transfer. Researchers will compare the clinical pregnancy outcomes between individualized embryo transfer guided by implantation window results and conventional embryo transfer, to observe whether implantation window-guided individualized embryo transfer can improve the clinical efficacy for patients with recurrent implantation failure (RIF). Participants will complete implantation window testing as required by the study protocol, undergo randomization and blinding, and proceed with embryo transfer according to their assigned group.
- Conditions
- Recurrent Implantation Failure
- Being tested
- Non-invasive endometrial receptivity prediction model guides personalized embryo transfer for patients with recurrent implantation failure (RIF).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive endometrial receptivity prediction model guides personalized embryo transfer for patients with recurrent implantation failure (RIF).Diagnostic test
Participants will undergo personalized embryo transfer based on the detection results of the window of implantation (WOI) via peripheral blood miRNA analysis. For subjects whose WOI results indicate that Day 5 (D5) is non-receptive, the embryo transfer timing will be appropriately advanced or delayed by 24 or 48 hours relative to the standard time. For subjects whose WOI results indicate that D5 is receptive, embryo transfer will be performed at the standard time (the fifth day after ovulation).
| Study group | Role | What they receive |
|---|---|---|
| Individualized Embryo Transfer Group | Experimental | Not described Receives: Diagnostic Test: Non-invasive endometrial receptivity prediction model guides personalized embryo transfer for patients with recurrent implantation failure (RIF). |
| Standard Embryo Transfer Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate per embryo transferred, assessed by counting gestational sacs on ultrasound.
Implantation rate is defined as the number of gestational sacs observed on ultrasound divided by the total number of embryos transferred. It will be expressed as a percentage: (Total number of gestational sacs / Total number of embryos transferred) × 100%. Assessment will occur approximately 35 days after embryo transfer.
Measured: From the day of embryo transfer until the completion of the first ultrasound assessment (typically at 35 days ± 7 days after transfer).
Secondary outcomes (3)
Proportion of patients with abnormal endometrial receptivity, as assessed by dynamic changes in peripheral blood microRNA levels 5 days after ovulation.
Endometrial receptivity will be assessed via the dynamic changes in specific microRNA expression profiles in peripheral blood, measured 5 days after ovulation (day of trigger). The "abnormal receptivity" (non-receptive) status is defined as a microRNA profile falling outside the established reference range for the receptive phase. The proportion will be calculated as: (Number of patients with a non-receptive microRNA profile / Total number of patients measured) × 100%.
Measured: From the day of ovulation trigger until the completion of microRNA sample collection and analysis (within 5 to 7 days post-trigger).
Clinical pregnancy rate per embryo transfer, confirmed by ultrasound visualization of gestational sac and fetal heartbeat.
Clinical pregnancy is defined as the presence of at least one intrauterine gestational sac with detectable fetal cardiac activity on transvaginal ultrasound. The rate will be calculated as: (Number of cycles achieving clinical pregnancy / Number of cycles with embryo transfer) × 100%.
Measured: From the day of embryo transfer until the confirmation of clinical pregnancy by ultrasound (assessed at approximately 35 days ± 7 days after embryo transfer).
Ongoing Pregnancy Rate per embryo transfer, confirmed by ultrasound after 12 weeks of gestation.
Ongoing pregnancy is defined as an intrauterine pregnancy with confirmed fetal viability beyond 12 weeks of gestation (i.e., after the first trimester). The rate will be calculated as the number of cycles achieving an ongoing pregnancy divided by the number of cycles with embryo transfer, expressed as a percentage: (Number of ongoing pregnancies / Number of embryo transfer cycles) × 100%. Fetal viability will be assessed via transvaginal or abdominal ultrasound, demonstrating the presence of fetal cardiac activity.
Measured: From the day of embryo transfer until the confirmation of fetal viability at or after 12 weeks of gestation (typically up to 14 weeks of gestation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Implantation FailureStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 546 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363018
- Sponsor's protocol ID
- 20251123
- Acronym
- RIF
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Non-Invasive Endometrial Receptivity Prediction Model Based on Peripheral Blood miRNA Signatures During the Peri-Implantation Period in Improving IVF Outcomes in Patients With Unexplained Recurrent Implantation Failure: A Prospective, Single-Blind, Two-Arm, Parallel Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07363018
- Acronym / sponsor ID
- RIF / 20251123
- Conditions
- Recurrent Implantation Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 546 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Jan 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.
The goal of this clinical trial aims to investigate whether a non-invasive implantation window prediction model, constructed based on characteristic changes in peripheral blood miRNAs during the peri-implantation period, can improve pregnancy outcomes in patients with unexplained recurrent implantation failure undergoing frozen embryo transfer. Researchers will compare the clinical pregnancy outcomes between individualized embryo transfer guided by implantation window results and conventional embryo transfer, to observe whether implantation window-guided individualized embryo transfer can improve the clinical efficacy for patients with recurrent implantation failure (RIF). Participants will complete implantation window testing as required by the study protocol, undergo randomization and blinding, and proceed with embryo transfer according to their assigned group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Embryo Transfer Group | Experimental | Diagnostic Test: Non-invasive endometrial receptivity prediction model guides personalized embryo transfer for patients with recurrent implantation failure (RIF). |
| Standard Embryo Transfer Group | No intervention | – |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with unexplained recurrent implantation failure (RIF) meeting the diagnostic criteria for RIF: adult women under 40 years old who have failed to achieve clinical pregnancy after 3 embryo transfer cycles; or after transferring at least 3 high-quality embryos.
- Definition of high-quality embryos: Day 3 embryos (with a cell count ≥7 and fragmentation rate <10%) and blastocysts (≥3BB).
- Female BMI: 18.5-25 kg/m².
- Endometrial thickness ≥7 mm during the embryo transfer cycle.
- Women planning to undergo frozen-thawed embryo transfer (FET) of blastocysts following in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
Key exclusion criteria (4 listed)
- Known causes of embryo implantation failure, such as infections, reproductive tract malformations, uterine cavity factors, adenomyosis or endometriosis, autoimmune system diseases (diagnosed by immunology department), hydrosalpinx, etc.
- Couples with chromosomal abnormalities (excluding chromosomal polymorphisms) or familial genetic disorders in either or both partners.
- Women with a history of recurrent miscarriage.
- Women with contraindications to pregnancy or assisted reproductive technology.
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 |
|---|---|---|
| Non-invasive endometrial receptivity prediction model guides personalized embryo transfer for patients with recurrent implantation failure (RIF).Participants will undergo personalized embryo transfer based on the detection results of the window of implantation (WOI) via peripheral blood miRNA analysis. For subjects whose WOI results indicate that Day 5 (D5) is non-receptive, the embryo transfer timing will be appropriately advanced or delayed by 24 or 48 hours relative to the standard time. For subjects whose WOI results indicate that D5 is receptive, embryo transfer will be performed at the standard time (the fifth day after ovulation). | Diagnostic test | Individualized Embryo Transfer Group |
Primary outcome
Implantation rate per embryo transferred, assessed by counting gestational sacs on ultrasound.
Time frame: From the day of embryo transfer until the completion of the first ultrasound assessment (typically at 35 days ± 7 days after transfer).
Implantation rate is defined as the number of gestational sacs observed on ultrasound divided by the total number of embryos transferred. It will be expressed as a percentage: (Total number of gestational sacs / Total number of embryos transferred) × 100%. Assessment will occur approximately 35 days after embryo transfer.
3 secondary outcomes
Proportion of patients with abnormal endometrial receptivity, as assessed by dynamic changes in peripheral blood microRNA levels 5 days after ovulation.
Time frame: From the day of ovulation trigger until the completion of microRNA sample collection and analysis (within 5 to 7 days post-trigger).
Clinical pregnancy rate per embryo transfer, confirmed by ultrasound visualization of gestational sac and fetal heartbeat.
Time frame: From the day of embryo transfer until the confirmation of clinical pregnancy by ultrasound (assessed at approximately 35 days ± 7 days after embryo transfer).
Ongoing Pregnancy Rate per embryo transfer, confirmed by ultrasound after 12 weeks of gestation.
Time frame: From the day of embryo transfer until the confirmation of fetal viability at or after 12 weeks of gestation (typically up to 14 weeks of gestation).
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 23 Jan 2026.
Related trials for Recurrent Implantation Failure
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
RecruitingPhase 2/3
Thymosin-α1 for Recurrent Implantation Failure
Recurrent Implantation Faliure
Not yet recruitingObservational study
Endometrial Immune Profile in Recurrent Implantation Failure
Recurrent Implantation Failure, Infertility (IVF Patients)
Not yet recruiting
Effects of Different Acupuncture Techniques on the Success Rate in Patients With Recurrent Implantation Failure
Implantation Failure
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive endometrial receptivity prediction model guides personalized embryo transfer for patients with recurrent implantation failure (RIF). in people with Recurrent Implantation Failure, run by Tang-Du Hospital.
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 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: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Implantation rate per embryo transferred, assessed by counting gestational sacs on ultrasound. (time frame: From the day of embryo transfer until the completion of the first ultrasound assessment (typically at 35 days ± 7 days after transfer).). 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 23 Jan 2026.