InfertilityNCT05730764
A Prediction Model and Assisted Decision-making System of Fertilization Disorders
A study testing Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-making and Clinicians follow a routine protocol in people with Infertility, run by Peking University Third Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to test the accuracy of the forecasting system we develop. The main question it aims to answer is: Whether the clinical prediction system predicts the incidence of fertilization disorders accurately. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-making and Clinicians follow a routine protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2024to 1 Aug 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertile couples
- have indications for acceptance of IVF or ICSI
- Both parties sign an informed consent form and can complete the follow-up visit
Who cannot join
- At least one of the spouses has contraindics to IVF or ICSI
- Major diseases
- Fresh cycle, PGT, IVM
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yuanyuan Wang, PhD, 13811352300 ext. 82266356, yyuanwang@163.com
About this study
Official title: A Prediction Model and Assisted Decision-making System of Fertilization Disorders: a Single-center Randomized Controlled Trial
The goal of this clinical trial is to test the accuracy of the forecasting system we develop. The main question it aims to answer is:
- Whether the clinical prediction system predicts the incidence of fertilization disorders accurately.
- The fertilization disorder prediction system predicts whether and how much the outcome differs from the doctor.
Participants will receive treatment assisted by a predictive system or receive general treatment.
Researchers will compare incidence of fertilization disorders to see if the fertilization disorder prediction system makes correct predictions.
Read the detailed description
Through the design method of single-center randomized controlled trial, 260 infertility patients were recruited, and they were divided into two groups of 130 cases in each group according to the method of block randomization, one of which was the intervention group, with the help of accurate prediction of fertilization disorders and clinical decision support systems, clinicians predicted and judged the probability and key factors of fertilization disorders of patients, and formulated and implemented personalized diagnosis and treatment plans based on the prediction results; The other group is the control group, which is treated by clinicians according to the conventional diagnosis and treatment plan, and the system performs parallel simulation operation to predict the outcome of fertilization disorders in patients without affecting any diagnosis and treatment decisions of clinicians. Through the comparison of the two groups, the predictive ability of the system for fertilization disorders was evaluated, and the effectiveness and safety of the personalized diagnosis and treatment plan formulated with the assistance of the system were observed, the primary observation outcomes were the incidence of fertilization disorders, and the secondary observation outcomes were embryo transfer rate, biochemical pregnancy rate, clinical pregnancy rate, etc.
- Conditions
- Infertility
- Being tested
- Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-making, Clinicians follow a routine protocol
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-makingDiagnostic test
With the assistance of accurate prediction of fertilization disorders and clinical decision support systems, clinicians predict and judge the probability and key factors of fertilization disorders of patients, and formulate and implement personalized diagnosis and treatment plans based on the prediction results
Clinicians follow a routine protocolDiagnostic test
Treatment is performed by the clinician according to the usual protocol.
| Study group | Role | What they receive |
|---|---|---|
| Support systems assist doctors in decision-making | Experimental | Doctors judge the risk of fertilization disorders and make clinical decisions with the support of a decision-making system. Receives: Diagnostic Test: Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-making |
| Clinicians follow a routine protocol | Other | Doctors judge the risk of fertilization disorders and make clinical decisions based on clinical experience Receives: Diagnostic Test: Clinicians follow a routine protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of fertilization disorders
Occurrence of fertilization disorders in participants
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start15 Jan 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730764
- Sponsor's protocol ID
- IRB00006761-M2022487
- Status last verified
- Nov 2022
- First submitted
- 16 Jan 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prediction Model and Assisted Decision-making System of Fertilization Disorders: a Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05730764
- Acronym / sponsor ID
- IRB00006761-M2022487
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 16 Feb 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.
The goal of this clinical trial is to test the accuracy of the forecasting system we develop. The main question it aims to answer is:
- Whether the clinical prediction system predicts the incidence of fertilization disorders accurately.
- The fertilization disorder prediction system predicts whether and how much the outcome differs from the doctor.
Participants will receive treatment assisted by a predictive system or receive general treatment.
Researchers will compare incidence of fertilization disorders to see if the fertilization disorder prediction system makes correct predictions.
Detailed description
Through the design method of single-center randomized controlled trial, 260 infertility patients were recruited, and they were divided into two groups of 130 cases in each group according to the method of block randomization, one of which was the intervention group, with the help of accurate prediction of fertilization disorders and clinical decision support systems, clinicians predicted and judged the probability and key factors of fertilization disorders of patients, and formulated and implemented personalized diagnosis and treatment plans based on the prediction results; The other group is the control group, which is treated by clinicians according to the conventional diagnosis and treatment plan, and the system performs parallel simulation operation to predict the outcome of fertilization disorders in patients without affecting any diagnosis and treatment decisions of clinicians. Through the comparison of the two groups, the predictive ability of the system for fertilization disorders was evaluated, and the effectiveness and safety of the personalized diagnosis and treatment plan formulated with the assistance of the system were observed, the primary observation outcomes were the incidence of fertilization disorders, and the secondary observation outcomes were embryo transfer rate, biochemical pregnancy rate, clinical pregnancy rate, etc.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Support systems assist doctors in decision-making | Experimental | Diagnostic Test: Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-makingDoctors judge the risk of fertilization disorders and make clinical decisions with the support of a decision-making system. |
| Clinicians follow a routine protocol | Other | Diagnostic Test: Clinicians follow a routine protocolDoctors judge the risk of fertilization disorders and make clinical decisions based on clinical experience |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- infertile couples
- have indications for acceptance of IVF or ICSI
- Both parties sign an informed consent form and can complete the follow-up visit
Key exclusion criteria (3 listed)
- At least one of the spouses has contraindics to IVF or ICSI
- Major diseases
- Fresh cycle, PGT, IVM
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 |
|---|---|---|
| Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-makingWith the assistance of accurate prediction of fertilization disorders and clinical decision support systems, clinicians predict and judge the probability and key factors of fertilization disorders of patients, and formulate and implement personalized diagnosis and treatment plans based on the prediction results | Diagnostic test | Support systems assist doctors in decision-making |
| Clinicians follow a routine protocolTreatment is performed by the clinician according to the usual protocol. | Diagnostic test | Clinicians follow a routine protocol |
Primary outcome
Incidence of fertilization disorders
Time frame: through study completion, an average of 3 months
Occurrence of fertilization disorders in participants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-making and Clinicians follow a routine protocol in people with Infertility, run by Peking University Third Hospital 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang Liu, Bachelor (15373118916, liufang190106@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of fertilization disorders (time frame: through study completion, an average of 3 months). 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 22 Nov 2023.