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

Peking University

Status: Enrolling

Conditions: Infertility

Treatments: Diagnostic Test: Clinicians follow a routine protocol; Diagnostic Test: Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-making

Study type: Interventional

Funder types: Other

Identifiers

NCT05730764

IRB00006761-M2022487

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

260 participants in 2 patient groups

Support systems assist doctors in decision-making

Experimental group

Description:

Doctors judge the risk of fertilization disorders and make clinical decisions with the support of a decision-making system.

Treatment:

Diagnostic Test: Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-making

Clinicians follow a routine protocol

Other group

Description:

Doctors judge the risk of fertilization disorders and make clinical decisions based on clinical experience

Treatment:

Diagnostic Test: Clinicians follow a routine protocol