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

Infertility Clinical Trial

Official title:

A Prediction Model and Assisted Decision-making System of Fertilization Disorders: a Single-center Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730764
• Other study ID #: IRB00006761-M2022487
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: November 2022
• Source: Peking University Third Hospital
• Contact: Fang Liu, Bachelor
• Phone: 15373118916
• Email: liufang190106[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

• 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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
• Clinicians follow a routine protocol
Treatment is performed by the clinician according to the usual protocol.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of fertilization disorders	Occurrence of fertilization disorders in participants	through study completion, an average of 3 months