InfertilityNCT06799598
DUOSTIM and AI: is There a Difference Between Oocyte Performance in the Follicular and Luteal Phases?
An observational study of Infertility, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
In vitro fertilization (IVF) has revolutionized assisted reproductive techniques, bringing hope to thousands of people seeking to fulfill their dream of parenthood. However, patients with low ovarian reserve face additional challenges, such as limited response to ovarian stimulation and difficulty in obtaining… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- How many people
- 92 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2024to 15 Jan 2025
- How long will I take part?
- 30 Days
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women of reproductive age undergoing ovarian stimulation for in vitro fertilization (IVF)
Who may be able to join
- Patients undergoing IVF with DUOSTIM protocol and Magenta analysis of mature eggs.
Who cannot join
- Canceled Duostim Magenta IVF cycles
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Vida - Medicina Reprodutiva
Rio de Janeiro, Rio de Janeiro, 22793-080
About this study
In vitro fertilization (IVF) has revolutionized assisted reproductive techniques, bringing hope to thousands of people seeking to fulfill their dream of parenthood. However, patients with low ovarian reserve face additional challenges, such as limited response to ovarian stimulation and difficulty in obtaining good-quality eggs. Innovative protocols such as Duostim (dual stimulation) have shown promise in these cases, allowing the maximum number of eggs to be retrieved in a short period of time. In addition, technological advances in the analysis of the quality of mature eggs, such as the use of the Magenta tool, are transforming the way specialists evaluate and select the best gametes to increase the chances of success. This article explores how these approaches complement each other, offering new possibilities for patients with low ovarian reserve and raising the standards of reproductive medicine.
Read the detailed description
The analysis of the two stimulation phases in a Duostim protocol for IVF using the Magenta tool may have significant clinical relevance, especially in the context of patients with low ovarian reserve or who require optimization in the number of embryos available in IVF cycles in a short period of time. The Magenta tool, being based on AI and machine learning, can identify patterns related to the quality of oocytes and embryos obtained in both phases. This can help determine if there are significant differences in embryo competence between oocytes collected in the follicular phase and the luteal phase. Magenta-powered analysis can provide robust data to validate the Duostim protocol, identify subgroups that benefit most from it, and promote greater clinical efficiency in IVF treatments, especially in challenging cases. This approach can revolutionize the way personalized protocols are designed and monitored to maximize reproductive success. The aim of this study is to compare the two phases of ovarian stimulation - follicular and luteal - in patients undergoing the Duostim protocol, using the Magenta tool for detailed analysis of mature eggs obtained in each phase. The research seeks to identify differences in oocyte quality between the two stages, as well as to evaluate the efficiency of the protocol in maximizing results in patients with low ovarian reserve.
- Conditions
- Infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DuoStim1 | Follicular phase Stimulation | |
| DuoStim2 | Luteal Phase stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicular and luteal phase oocytes Magenta score
Assessment of oocyte potential to generate blastocysts at two different times of oocyte retrieval
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 May 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 92 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuri Ian Lima Alves de Oliveira, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799598
- Sponsor's protocol ID
- VD001/2025
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DUOSTIM and AI: is There a Difference Between Oocyte Performance in the Follicular and Luteal Phases?
- ClinicalTrials.gov ID
- NCT06799598
- Acronym / sponsor ID
- VD001/2025
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 29 Jan 2025 (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.
In vitro fertilization (IVF) has revolutionized assisted reproductive techniques, bringing hope to thousands of people seeking to fulfill their dream of parenthood. However, patients with low ovarian reserve face additional challenges, such as limited response to ovarian stimulation and difficulty in obtaining good-quality eggs. Innovative protocols such as Duostim (dual stimulation) have shown promise in these cases, allowing the maximum number of eggs to be retrieved in a short period of time. In addition, technological advances in the analysis of the quality of mature eggs, such as the use of the Magenta tool, are transforming the way specialists evaluate and select the best gametes to increase the chances of success. This article explores how these approaches complement each other, offering new possibilities for patients with low ovarian reserve and raising the standards of reproductive medicine.
Detailed description
The analysis of the two stimulation phases in a Duostim protocol for IVF using the Magenta tool may have significant clinical relevance, especially in the context of patients with low ovarian reserve or who require optimization in the number of embryos available in IVF cycles in a short period of time. The Magenta tool, being based on AI and machine learning, can identify patterns related to the quality of oocytes and embryos obtained in both phases. This can help determine if there are significant differences in embryo competence between oocytes collected in the follicular phase and the luteal phase. Magenta-powered analysis can provide robust data to validate the Duostim protocol, identify subgroups that benefit most from it, and promote greater clinical efficiency in IVF treatments, especially in challenging cases. This approach can revolutionize the way personalized protocols are designed and monitored to maximize reproductive success. The aim of this study is to compare the two phases of ovarian stimulation - follicular and luteal - in patients undergoing the Duostim protocol, using the Magenta tool for detailed analysis of mature eggs obtained in each phase. The research seeks to identify differences in oocyte quality between the two stages, as well as to evaluate the efficiency of the protocol in maximizing results in patients with low ovarian reserve.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DuoStim1 | – | –Follicular phase Stimulation |
| DuoStim2 | – | –Luteal Phase stimulation |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women of reproductive age undergoing ovarian stimulation for in vitro fertilization (IVF)
Key inclusion criteria (1 listed)
- Patients undergoing IVF with DUOSTIM protocol and Magenta analysis of mature eggs.
Key exclusion criteria (1 listed)
- Canceled Duostim Magenta IVF cycles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Follicular and luteal phase oocytes Magenta score
Time frame: 30 days
Assessment of oocyte potential to generate blastocysts at two different times of oocyte retrieval
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
Related trials for Infertility
RecruitingPhase 3
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Infertility
Active, not recruitingObservational study
Fresh Versus Vitrified-Warmed Donor Oocytes: Embryological and Clinical Outcomes
Infertility, Donor Oocyte Assisted Reproduction
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
Not yet recruiting
Implementing IVM for Fertility Treatment in Clinical Practice
Infertility
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infertility, run by Rio de Janeiro State University at 1 site in Brazil.
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: finished, as of the sponsor's last update on 29 Jan 2025. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follicular and luteal phase oocytes Magenta score (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2025.