Comparison of Follitropin Delta and Follitropin Alfa in Combination With Menotropin (NCT07457684) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Follitropin Delta and Follitropin Alfa in Combination With Menotropin
Canada846 participantsStarted 2025-12-05
Plain-language 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).
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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of utilizable blastocysts per treatment cycle
Timeframe: For IVF performed from January 2018 to December 2024