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

Not yet recruiting

• Conditions: Fertility Issues
• Interventions: Other: total cumulative gonadotrophin usage

• Registration Number: NCT06179420
• Lead Sponsor: National University of Malaysia

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2023-12-10
• Study First Submitted QC: 2023-12-12
• Study First Posted: 2023-12-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Study Start: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Patient undergoing 2nd cycle of IVF

Exclusion Criteria

• Polycystic ovarian syndrome patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
clinical decision support tool, Opt-IVF for IVF regime protocol	total cumulative gonadotrophin usage	The dosage of gonadotrophin and time of transvaginal ultrasound decided by a clinical decision support tool ( OPt -IVF)
standard IVF regime protocol based on clinician decision	total cumulative gonadotrophin usage	The dosage of gonadotrophin and time of transvaginal ultrasound decided by clinician

Primary Outcome Measures

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

Trial Locations

Locations (1)

Advanced Reproductive Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia