- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07457684
Comparison of Follitropin Delta and Follitropin Alfa in Combination With Menotropin (BONANZA)
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:
- 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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Quebec
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Montreal, Quebec, Canada, H4P 2S4
- Clinique ovo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Follitropin alfa (Gonal-F®) + HP-hMG (Menopur®)
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Follitropin delta (Rekovelle®) + HP-hMG (Menopur®)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of utilizable blastocysts per treatment cycle
Time Frame: For IVF performed from January 2018 to December 2024
|
For IVF performed from January 2018 to December 2024
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of stimulation days
Time Frame: For IVF performed from January 2018 to December 2024
|
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
|
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
|
For IVF performed from January 2018 to December 2024
|
|
Number of retrieved oocytes
Time Frame: For IVF performed from January 2018 to December 2024
|
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
|
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
|
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
|
For IVF performed from January 2018 to December 2024
|
|
Pregnancy rates
Time Frame: For IVF performed from January 2018 to December 2024
|
For IVF performed from January 2018 to December 2024
|
|
Cost per blastocyst
Time Frame: For IVF performed from January 2018 to December 2024
|
For IVF performed from January 2018 to December 2024
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Isaac-Jacques Kadoch, MD, Clinique ovo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BONANZA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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