A Prediction Model and Assisted Decision-making System of Fertilization Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility
• Intervention / Treatment: Diagnostic test: Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-making; Diagnostic test: Clinicians follow a routine protocol

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 Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Liu, Bachelor; Phone Number: 15373118916; Email: liufang190106@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Yuanyuan Wang, PhD; Phone Number: 82266356 13811352300; Email: yyuanwang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. infertile couples
2. have indications for acceptance of IVF or ICSI
3. Both parties sign an informed consent form and can complete the follow-up visit

Exclusion Criteria:

1. At least one of the spouses has contraindics to IVF or ICSI
2. Major diseases
3. Fresh cycle, PGT, IVM

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Support systems assist doctors in decision-making; Doctors judge the risk of fertilization disorders and make clinical decisions with the support of a decision-making system.	Diagnostic test: Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-making; 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
Other: Clinicians follow a routine protocol; Doctors judge the risk of fertilization disorders and make clinical decisions based on clinical experience	Diagnostic test: Clinicians follow a routine protocol; Treatment is performed by the clinician according to the usual protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of fertilization disorders	Occurrence of fertilization disorders in participants	through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: IRB00006761-M2022487

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No