Fertility IssuesNCT06179420
The Effectiveness of Advanced Decision Support Tool (OPT-IVF) for IVF Treatment
An observational study of Fertility Issues, run by National University of Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Issues
- What is being tested?
- total cumulative gonadotrophin usage
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 13 Mar 2024to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patient who had failed their first IVF treatment
Who may be able to join
- Patient undergoing 2nd cycle of IVF
Who cannot join
- Polycystic ovarian syndrome patient
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Advanced Reproductive Centre
Kuala Lumpur, Kuala Lumpur, 56000
About this study
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.
Read the detailed description
The total dosage of gonadotrophin, number of good quality oocytes and blastocyst will be analyzed from each arm.
- Conditions
- Fertility Issues
- Being tested
- total cumulative gonadotrophin usage
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total cumulative gonadotrophin usageOther
Also called number of matured oocytes, number of qood quality blastocyst
total dosage in IU
| Study group | Role | What they receive |
|---|---|---|
| standard IVF regime protocol based on clinician decision | The dosage of gonadotrophin and time of transvaginal ultrasound decided by clinician Receives: Other: total cumulative gonadotrophin usage | |
| 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) Receives: Other: total cumulative gonadotrophin usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
total cumulative dosage of Gonadotropins
number of total dosage that utilize during one cycle of IVF treatment
Measured: for 1 year duration
Total number of matured oocytes
number of matured oocytes following the stimulation protocol
Measured: for 1 year duration
total number of good quality blastocyst
total blastocyst achieved after each sti,ulation protocol
Measured: for 1 year duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start13 Mar 2024 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azrai Abu, National University of Malaysia
- Investigators
- Muhammad Azrai Abu, MD, Principal investigator, Department Of Obstetrics And Gynecology, Ukm Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179420
- Sponsor's protocol ID
- UKMPPI/111/8/JEP-2023-735
- Status last verified
- Mar 2024
- First submitted
- 10 Dec 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34493094Simopoulou 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.
PubMed 30088950Hariton 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.
PubMed 34256948Fanton 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.
PubMed 36096871Correa 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.
PubMed 35915001Curchoe 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.
PubMed 33160514
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Advanced Decision Support Tool (OPT-IVF) for IVF Treatment
- ClinicalTrials.gov ID
- NCT06179420
- Acronym / sponsor ID
- UKMPPI/111/8/JEP-2023-735
- Conditions
- Fertility Issues
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 13 Mar 2024 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard IVF regime protocol based on clinician decision | – | Other: total cumulative gonadotrophin usageThe dosage of gonadotrophin and time of transvaginal ultrasound decided by clinician |
| clinical decision support tool, Opt-IVF for IVF regime protocol | – | Other: total cumulative gonadotrophin usageThe dosage of gonadotrophin and time of transvaginal ultrasound decided by a clinical decision support tool ( OPt -IVF) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patient who had failed their first IVF treatment
Key inclusion criteria (1 listed)
- Patient undergoing 2nd cycle of IVF
Key exclusion criteria (1 listed)
- Polycystic ovarian syndrome patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total cumulative gonadotrophin usageAlso: number of matured oocytes, number of qood quality blastocysttotal dosage in IU | Other | clinical decision support tool, Opt-IVF for IVF regime protocol, standard IVF regime protocol based on clinician decision |
Primary outcome
total cumulative dosage of Gonadotropins
Time frame: for 1 year duration
number of total dosage that utilize during one cycle of IVF treatment
Total number of matured oocytes
Time frame: for 1 year duration
number of matured oocytes following the stimulation protocol
total number of good quality blastocyst
Time frame: for 1 year duration
total blastocyst achieved after each sti,ulation protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Results publication: PubMed 34493094Leahy 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.
- Results publication: PubMed 30088950Simopoulou 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.
- Results publication: PubMed 34256948Hariton 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.
- Results publication: PubMed 36096871Fanton 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.
- Results publication: PubMed 35915001Correa 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.
- Results publication: PubMed 33160514Curchoe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Azrai Abu, MD principal investigator
Department Of Obstetrics And Gynecology, Ukm Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Issues, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Azrai Abu (+60196410944, azraiabu1983@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total cumulative dosage of Gonadotropins (time frame: for 1 year duration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06179420, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.