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

Fertility Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06179420
• Other study ID #: UKMPPI/111/8/JEP-2023-735
• Status: Not yet recruiting
• Start date: March 13, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: March 2024
• Source: National University of Malaysia
• Contact: Muhammad Azrai Abu
• Phone: +60196410944
• Email: azraiabu1983[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patient undergoing 2nd cycle of IVF

Exclusion Criteria:

• Polycystic ovarian syndrome patient

Related Conditions & MeSH terms

• Fertility Issues
• Infertility

Intervention

Other:
• total cumulative gonadotrophin usage
total dosage in IU

Locations

Country	Name	City	State
Malaysia	Advanced Reproductive Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (6)

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. — View 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. — View Citation

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 O — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Outcome

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