MedDataX Logo

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

NCT ID: NCT05730764

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

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

Intervention Type 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

Clinicians follow a routine protocol

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

Group Type OTHER

Clinicians follow a routine protocol

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Clinicians follow a routine protocol

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fang Liu, Bachelor

Role: CONTACT

[email protected]
15373118916

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yuanyuan Wang, PhD

Role: primary

[email protected]
13811352300 ext. 82266356

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00006761-M2022487

Identifier Type: -

Identifier Source: org_study_id