A Prediction Model and Assisted Decision-making System of Fertilization Disorders
Primary Purpose
Infertility
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-making
Clinicians follow a routine protocol
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility
Eligibility Criteria
Inclusion Criteria: infertile couples have indications for acceptance of IVF or ICSI Both parties sign an informed consent form and can complete the follow-up visit Exclusion Criteria: At least one of the spouses has contraindics to IVF or ICSI Major diseases Fresh cycle, PGT, IVM
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Support systems assist doctors in decision-making
Clinicians follow a routine protocol
Arm Description
Doctors judge the risk of fertilization disorders and make clinical decisions with the support of a decision-making system.
Doctors judge the risk of fertilization disorders and make clinical decisions based on clinical experience
Outcomes
Primary Outcome Measures
Incidence of fertilization disorders
Occurrence of fertilization disorders in participants
Secondary Outcome Measures
Full Information
NCT ID
NCT05730764
First Posted
January 16, 2023
Last Updated
February 15, 2023
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05730764
Brief Title
A Prediction Model and Assisted Decision-making System of Fertilization Disorders
Official Title
A Prediction Model and Assisted Decision-making System of Fertilization Disorders: a Single-center Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 28, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Support systems assist doctors in decision-making
Arm Type
Experimental
Arm Description
Doctors judge the risk of fertilization disorders and make clinical decisions with the support of a decision-making system.
Arm Title
Clinicians follow a routine protocol
Arm Type
Other
Arm Description
Doctors judge the risk of fertilization disorders and make clinical decisions based on clinical experience
Intervention Type
Diagnostic Test
Intervention Name(s)
Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-making
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Clinicians follow a routine protocol
Intervention Description
Treatment is performed by the clinician according to the usual protocol.
Primary Outcome Measure Information:
Title
Incidence of fertilization disorders
Description
Occurrence of fertilization disorders in participants
Time Frame
through study completion, an average of 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
infertile couples
have indications for acceptance of IVF or ICSI
Both parties sign an informed consent form and can complete the follow-up visit
Exclusion Criteria:
At least one of the spouses has contraindics to IVF or ICSI
Major diseases
Fresh cycle, PGT, IVM
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Liu, Bachelor
Phone
15373118916
Email
liufang190106@163.com
12. IPD Sharing Statement
Learn more about this trial
A Prediction Model and Assisted Decision-making System of Fertilization Disorders
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