The Effectiveness of Advanced Decision Support Tool (OPT-IVF) for IVF Treatment

March 12, 2024 updated by: Azrai Abu, National University of Malaysia

This prospective study is subject to approval of institutional medical research ethics committee. Patient undergoing second cycle IVF will be enrolled into the intervention group. Intervention involved using a clinical decision support tool, Opt-IVF to guide gonadotrophins dosing and trigger dates for a personalized controlled ovarian stimulation cycle based on the distribution of follicle sizes on day 1 and day 5, and hormone dosages given on day 1 to 4.

Patients will undergo transvaginal ultrasound exam on day 1 and day 5 of the cycle to determine the number and size of follicles present. The data is used in the Opt-IVF decision support tool to suggest Gonadotropin dosage for D5 and beyond and to recommend the antagonist start day and trigger day.

Clinical investigators will not override the Opt-IVF recommended dosage in any patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The total dosage of gonadotrophin, number of good quality oocytes and blastocyst will be analyzed from each arm.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Wilayah Persekutuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 56000
        • Advanced Reproductive Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patient who had failed their first IVF treatment

Description

Inclusion Criteria:

  • Patient undergoing 2nd cycle of IVF

Exclusion Criteria:

  • Polycystic ovarian syndrome patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
standard IVF regime protocol based on clinician decision
The dosage of gonadotrophin and time of transvaginal ultrasound decided by clinician
Other: total cumulative gonadotrophin usage
total dosage in IU
Other Names:
  • number of matured oocytes
  • number of qood quality blastocyst
clinical decision support tool, Opt-IVF for IVF regime protocol
The dosage of gonadotrophin and time of transvaginal ultrasound decided by a clinical decision support tool ( OPt -IVF)
Other: total cumulative gonadotrophin usage
total dosage in IU
Other Names:
  • number of matured oocytes
  • number of qood quality blastocyst

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total cumulative dosage of Gonadotropins
Time Frame: for 1 year duration
number of total dosage that utilize during one cycle of IVF treatment
for 1 year duration
Total number of matured oocytes
Time Frame: for 1 year duration
number of matured oocytes following the stimulation protocol
for 1 year duration
total number of good quality blastocyst
Time Frame: for 1 year duration
total blastocyst achieved after each sti,ulation protocol
for 1 year duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Investigators

  • Principal Investigator: Muhammad Azrai Abu, MD, Department Of Obstetrics And Gynecology, Ukm Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 13, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

December 10, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKMPPI/111/8/JEP-2023-735

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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