Clinical trial NCT06179420: The Effectiveness of Advanced Decision Support Tool (OPT-IVF) for IVF Treatment
Official title: The Effectiveness of Advanced Decision Support Tool (OPT-IVF) for IVF Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fertility Issues
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient who had failed their first IVF treatment

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.

Eligibility criteria: Inclusion Criteria:

* Patient undergoing 2nd cycle of IVF

Exclusion Criteria:

* Polycystic ovarian syndrome patient

Primary outcomes:
measure: total cumulative dosage of Gonadotropins
timeFrame: for 1 year duration
measure: Total number of matured oocytes
timeFrame: for 1 year duration
measure: total number of good quality blastocyst
timeFrame: for 1 year duration
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Advanced Reproductive Centre
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: Department Of Obstetrics And Gynecology, Ukm Medical Centre
name: Muhammad Azrai Abu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.