CClinicalTrials.gg
Status unknownNCT05730764Updated Nov 22, 2023

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

An interventional study of Accurate prediction of fertilization disorders and clinical decision support systems assist doctors in decision-making and Clinicians follow a routine protocol in Infertility, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Infertility

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03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 260 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. At least one of the spouses has contraindics to IVF or ICSI
  2. Major diseases
  3. Fresh cycle, PGT, IVM
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
260 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Diagnostic testAccurate 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

  • Diagnostic testClinicians follow a routine protocol

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

06

What researchers measure

Primary outcomes

  1. Incidence of fertilization disorders

    Occurrence of fertilization disorders in participants

    Time frame: through study completion, an average of 3 months

07

Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, Beijing 100191, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05730764
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
Feb 16, 2023
Start date
Jan 15, 2024 (estimated)
Primary completion
Aug 1, 2024 (estimated)
Completion
Aug 1, 2024 (estimated)
Last update
Nov 22, 2023

Study contacts

Fang Liu, Bachelor
Contact
liufang190106@163.com
15373118916

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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