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

NCT ID: NCT06179420

Last Updated: 2024-03-15

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

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-13

Study Completion Date

2026-01-31

Brief Summary

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

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.

Detailed Description

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

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

Conditions

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

Fertility Issues

Study Design

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

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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

standard IVF regime protocol based on clinician decision

The dosage of gonadotrophin and time of transvaginal ultrasound decided by clinician

total cumulative gonadotrophin usage

Intervention Type OTHER

total dosage in IU

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)

total cumulative gonadotrophin usage

Intervention Type OTHER

total dosage in IU

Interventions

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

total cumulative gonadotrophin usage

total dosage in IU

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

number of matured oocytes number of qood quality blastocyst

Eligibility Criteria

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

Inclusion Criteria

* Patient undergoing 2nd cycle of IVF

Exclusion Criteria

* Polycystic ovarian syndrome patient
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

National University of Malaysia

OTHER

Sponsor Role lead

Responsible Party

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

Azrai Abu

Associate Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Muhammad Azrai Abu, MD

Role: PRINCIPAL_INVESTIGATOR

Department Of Obstetrics And Gynecology, Ukm Medical Centre

Locations

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

Advanced Reproductive Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

Countries

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

Malaysia

Central Contacts

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

Muhammad Azrai Abu

Role: CONTACT

+60196410944

References

Explore related publications, articles, or registry entries linked to this study.

Leahy BD, Racowsky C, Needleman D. Inferring simple but precise quantitative models of human oocyte and early embryo development. J R Soc Interface. 2021 Sep;18(182):20210475. doi: 10.1098/rsif.2021.0475. Epub 2021 Sep 8.

Reference Type RESULT
PMID: 34493094 (View on PubMed)

Simopoulou M, Sfakianoudis K, Antoniou N, Maziotis E, Rapani A, Bakas P, Anifandis G, Kalampokas T, Bolaris S, Pantou A, Pantos K, Koutsilieris M. Making IVF more effective through the evolution of prediction models: is prognosis the missing piece of the puzzle? Syst Biol Reprod Med. 2018 Oct;64(5):305-323. doi: 10.1080/19396368.2018.1504347. Epub 2018 Aug 8.

Reference Type RESULT
PMID: 30088950 (View on PubMed)

Hariton E, Chi EA, Chi G, Morris JR, Braatz J, Rajpurkar P, Rosen M. A machine learning algorithm can optimize the day of trigger to improve in vitro fertilization outcomes. Fertil Steril. 2021 Nov;116(5):1227-1235. doi: 10.1016/j.fertnstert.2021.06.018. Epub 2021 Jul 10.

Reference Type RESULT
PMID: 34256948 (View on PubMed)

Fanton M, Nutting V, Rothman A, Maeder-York P, Hariton E, Barash O, Weckstein L, Sakkas D, Copperman AB, Loewke K. An interpretable machine learning model for individualized gonadotrophin starting dose selection during ovarian stimulation. Reprod Biomed Online. 2022 Dec;45(6):1152-1159. doi: 10.1016/j.rbmo.2022.07.010. Epub 2022 Jul 28.

Reference Type RESULT
PMID: 36096871 (View on PubMed)

Correa N, Cerquides J, Arcos JL, Vassena R. Supporting first FSH dosage for ovarian stimulation with machine learning. Reprod Biomed Online. 2022 Nov;45(5):1039-1045. doi: 10.1016/j.rbmo.2022.06.010. Epub 2022 Jun 18.

Reference Type RESULT
PMID: 35915001 (View on PubMed)

Curchoe CL, Flores-Saiffe Farias A, Mendizabal-Ruiz G, Chavez-Badiola A. Evaluating predictive models in reproductive medicine. Fertil Steril. 2020 Nov;114(5):921-926. doi: 10.1016/j.fertnstert.2020.09.159.

Reference Type RESULT
PMID: 33160514 (View on PubMed)

Other Identifiers

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

UKMPPI/111/8/JEP-2023-735

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Retrospective Database Studies
NCT01219296 COMPLETED
ReceptIVFity & Immunology in ART
NCT06709976 ENROLLING_BY_INVITATION
Bed Rest or no Bed Rest?
NCT01343992 COMPLETED NA