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

NCT05730764 | Unknown

• 1 other identifier: IRB00006761-M2022487
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Incidence of fertilization disorders

  Occurrence of fertilization disorders in participants

  through study completion, an average of 3 months

Study Arms (2)

Support systems assist doctors in decision-making

EXPERIMENTAL

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

Clinicians follow a routine protocol

OTHER

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

Diagnostic Test: Clinicians follow a routine protocol

Interventions

Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-making DIAGNOSTIC_TEST

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

Support systems assist doctors in decision-making

Clinicians follow a routine protocol DIAGNOSTIC_TEST

Treatment is performed by the clinician according to the usual protocol.

Clinicians follow a routine protocol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• At least one of the spouses has contraindics to IVF or ICSI
• Major diseases
• Fresh cycle, PGT, IVM

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Fang Liu, Bachelor

CONTACT

15373118916; liufang190106@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 16, 2023
• Study Start: January 15, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 22, 2023

Record last verified: 2022-11

Locations

CN (1)