IVF OutcomesBONANZANCT07457684
Comparison of Follitropin Delta and Follitropin Alfa in Combination With Menotropin
An observational study of IVF Outcomes and OVARIAN STIMULATION, run by Clinique Ovo at 1 site in Canada.
Trial summary
The goal of this retrospective study is to compare the effectiveness and cost-effectiveness of two mixed ovarian stimulation protocols in women undergoing in vitro fertilization (IVF). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- IVF Outcomes, OVARIAN STIMULATION
- How many people
- 846 participants
- Where
- 1 siteCanada
- Study dates
- 5 Dec 2025to 15 Dec 2025
- 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
- No healthy volunteers
- Adult
Study population: Women who underwent their first IVF cycle between 2018 and 2024 at the ovo clinic
Who may be able to join
- Women between 18-45 years included
- First ovarian stimulation cycle only
- Patients who used mixed protocols combining menotropin and follitropin alfa or delta
- Patients whose Rekovelle doses were prescribed using the algorithm based on AMH and weight.
Who cannot join
- Patients who did not follow the algorithm to determine follitropin delta dosing and who required dose adjustments during the stimulation
- Patients who took concomitant treatment, such as corticosteroids, low molecular weight heparin, nonsteroidal anti-inflammatory drugs, recombinant LH or intra-vaginal vasodilators
- Oocytes donation or fertility preservation cycles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Follitropin Delta and Follitropin Alfa in Combination With Menotropin (the BONANZA Study)
The goal of this retrospective study is to compare the effectiveness and cost-effectiveness of two mixed ovarian stimulation protocols in women undergoing in vitro fertilization (IVF).
The main questions it aims to answer are:
Read more
- Does the combination of follitropin delta + HP-hMG result in a higher number of utilizable blastocysts per treatment cycle compared to follitropin alfa + HP-hMG?
- Does the follitropin delta based mixed protocol reduce total gonadotropin dose and cost per usable blastocyst while maintaining or improving pregnancy outcomes?
Researchers will compare follitropin alfa (Gonal-F®) + HP-hMG (Menopur®) with follitropin delta (Rekovelle®) + HP-hMG (Menopur®) to determine which protocol improves ovarian response, embryology outcomes, pregnancy rates, and overall treatment cost-efficiency.
- Conditions
- IVF Outcomes, OVARIAN STIMULATION
- Keywords
- follitropin delta, follitropin alfa, menotropins, IVF
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 |
|---|---|---|
| Follitropin alfa (Gonal-F®) + HP-hMG (Menopur®) | Not described | |
| Follitropin delta (Rekovelle®) + HP-hMG (Menopur®) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of utilizable blastocysts per treatment cycle
Measured: For IVF performed from January 2018 to December 2024
Secondary outcomes (9)
Number of stimulation days
Measured: For IVF performed from January 2018 to December 2024
Totals doses of rFSH, HP-hMG, and FSH
Measured: For IVF performed from January 2018 to December 2024
Costs of rFSH, HP-hMG, and FSH
Measured: For IVF performed from January 2018 to December 2024
Number of retrieved oocytes
Measured: For IVF performed from January 2018 to December 2024
Number of mature oocytes (MII)
Measured: For IVF performed from January 2018 to December 2024
Number of fertilized oocytes (2PN)
Measured: For IVF performed from January 2018 to December 2024
Total FSH/ usable blastocysts ratio
Measured: For IVF performed from January 2018 to December 2024
Pregnancy rates
Measured: For IVF performed from January 2018 to December 2024
Cost per blastocyst
Measured: For IVF performed from January 2018 to December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start5 Dec 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVF OutcomesStudies 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
- Retrospective
- Enrolment
- 846 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isaac-Jacques Kadoch, MD, Principal investigator, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457684
- Sponsor's protocol ID
- BONANZA
- Acronym
- BONANZA
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Follitropin Delta and Follitropin Alfa in Combination With Menotropin (the BONANZA Study)
- ClinicalTrials.gov ID
- NCT07457684
- Acronym / sponsor ID
- BONANZA / BONANZA
- Conditions
- IVF Outcomes, OVARIAN STIMULATION
- Keywords
- follitropin delta, follitropin alfa, menotropins, IVF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 846 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 9 Mar 2026 (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.
The goal of this retrospective study is to compare the effectiveness and cost-effectiveness of two mixed ovarian stimulation protocols in women undergoing in vitro fertilization (IVF).
The main questions it aims to answer are:
- Does the combination of follitropin delta + HP-hMG result in a higher number of utilizable blastocysts per treatment cycle compared to follitropin alfa + HP-hMG?
- Does the follitropin delta based mixed protocol reduce total gonadotropin dose and cost per usable blastocyst while maintaining or improving pregnancy outcomes?
Researchers will compare follitropin alfa (Gonal-F®) + HP-hMG (Menopur®) with follitropin delta (Rekovelle®) + HP-hMG (Menopur®) to determine which protocol improves ovarian response, embryology outcomes, pregnancy rates, and overall treatment cost-efficiency.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follitropin alfa (Gonal-F®) + HP-hMG (Menopur®) | – | – |
| Follitropin delta (Rekovelle®) + HP-hMG (Menopur®) | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who underwent their first IVF cycle between 2018 and 2024 at the ovo clinic
Key inclusion criteria (4 listed)
- Women between 18-45 years included
- First ovarian stimulation cycle only
- Patients who used mixed protocols combining menotropin and follitropin alfa or delta
- Patients whose Rekovelle doses were prescribed using the algorithm based on AMH and weight.
Key exclusion criteria (3 listed)
- Patients who did not follow the algorithm to determine follitropin delta dosing and who required dose adjustments during the stimulation
- Patients who took concomitant treatment, such as corticosteroids, low molecular weight heparin, nonsteroidal anti-inflammatory drugs, recombinant LH or intra-vaginal vasodilators
- Oocytes donation or fertility preservation 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
Number of utilizable blastocysts per treatment cycle
Time frame: For IVF performed from January 2018 to December 2024
9 secondary outcomes
Number of stimulation days
Time frame: For IVF performed from January 2018 to December 2024
Totals doses of rFSH, HP-hMG, and FSH
Time frame: For IVF performed from January 2018 to December 2024
Costs of rFSH, HP-hMG, and FSH
Time frame: For IVF performed from January 2018 to December 2024
Number of retrieved oocytes
Time frame: For IVF performed from January 2018 to December 2024
Number of mature oocytes (MII)
Time frame: For IVF performed from January 2018 to December 2024
Number of fertilized oocytes (2PN)
Time frame: For IVF performed from January 2018 to December 2024
Total FSH/ usable blastocysts ratio
Time frame: For IVF performed from January 2018 to December 2024
Pregnancy rates
Time frame: For IVF performed from January 2018 to December 2024
Cost per blastocyst
Time frame: For IVF performed from January 2018 to December 2024
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 9 Mar 2026.
- 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.
Isaac-Jacques Kadoch, MD principal investigator
Clinique Ovo
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 IVF Outcomes and OVARIAN STIMULATION, run by Clinique Ovo at 1 site in Canada.
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 4 inclusion and 3 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 9 Mar 2026. 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 Canada. 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?
Number of utilizable blastocysts per treatment cycle (time frame: For IVF performed from January 2018 to December 2024). 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 9 Mar 2026.