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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
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    January 16, 2023
    Last Updated
    February 15, 2023
    Sponsor
    Peking University Third Hospital
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    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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