IVFSTORMNCT05873725
Retrospective Study of High Dose Follitropin Delta in a Mixed Protocol With Human Chorionic Gonadotropin
An observational study of IVF and Infertility, run by Clinique Ovo at 1 site in Canada.
Trial summary
Follitropin delta is a rFSH, uniquely expressed in a human fetal retinal cell line, which owing to differences in glycosylation profile has a lower clearance and induces a higher ovarian response in humans than existing rFSH preparations when administered at equal doses of biological activity. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- IVF, Infertility
- What is being tested?
- Follitropin delta
- Type of treatment
- Injection or infusion
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- 20 May 2023to 19 Mar 2024
- 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 42 years
- Women only
- Adult
Study population: Women consulting the clinic for fertility issues that require in vitro fertilization
Who may be able to join
- Women 18 to 42 years of age undergoing IVF/ICSI cycle
- IVF antagonist protocol
- Regular menstrual cycles of 24-35 days
- Presence of both ovaries
Who cannot join
- Endometriosis stage III/IV
- History of recurrent miscarriages, defined as ≥ 3 consecutive losses
- Women undergoing ovarian stimulation for oncologic or elective fertility preservation
- Women participating in any other research project
- Hypersensitivity to follitropin delta and/or human chorionic gonadotropin
- Use of Growth Hormone (GH) during the stimulation cycle
Trial locations and contacts
1 site in 1 country.
About this study
Follitropin delta is a rFSH, uniquely expressed in a human fetal retinal cell line, which owing to differences in glycosylation profile has a lower clearance and induces a higher ovarian response in humans than existing rFSH preparations when administered at equal doses of biological activity. A noninferiority clinical trial (ESTHER-1) in which individualized dosage of follitropin delta according to each patient's profile (AMH and weight) was compared to conventional follitropin alfa dosing for IVF have demonstrated that an individualized follitropin delta dosing is noninferior to conventional follitropin alfa with respect to ongoing pregnancy rate, ongoing implantation rate, and also live births, with a concomitant reduction in iatrogenic complications, including OHSS
- Conditions
- IVF, Infertility
- Being tested
- Follitropin delta
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin deltaDrug
Evaluation of the IVF cycle using the prescribed medication
| Study group | Role | What they receive |
|---|---|---|
| Follitropin delta + hCG | Combination of follitropin delta and serial hCG injections at individualized doses, where dosing regimen was determined according to AMH and weight in women undergoing an IVF antagonist cycle Receives: Drug: Follitropin delta | |
| Follitropin delta + HP-hMG | Combination of follitropin delta and highly-purified human menopausal gonadotropin (HP-hMG) where dosing regimen was determined according to AMH and weight in women undergoing an IVF antagonist cycle Receives: Drug: Follitropin delta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of good quality blastocysts
Number of good quality oocytes fertilized
Measured: Up to 6 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start20 May 2023
- Primary completion30 Sep 2023
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies 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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacques Kadoch, MD, Principal investigator, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873725
- Sponsor's protocol ID
- 3282
- Acronym
- STORM
- Status last verified
- Dec 2025
- First submitted
- 15 May 2023
- Last updated
- 9 Dec 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of High Dose Follitropin Delta in a Mixed Protocol With Human Chorionic Gonadotropin
- ClinicalTrials.gov ID
- NCT05873725
- Acronym / sponsor ID
- STORM / 3282
- Conditions
- IVF, Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- 20 May 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 24 May 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.
Follitropin delta is a rFSH, uniquely expressed in a human fetal retinal cell line, which owing to differences in glycosylation profile has a lower clearance and induces a higher ovarian response in humans than existing rFSH preparations when administered at equal doses of biological activity. A noninferiority clinical trial (ESTHER-1) in which individualized dosage of follitropin delta according to each patient's profile (AMH and weight) was compared to conventional follitropin alfa dosing for IVF have demonstrated that an individualized follitropin delta dosing is noninferior to conventional follitropin alfa with respect to ongoing pregnancy rate, ongoing implantation rate, and also live births, with a concomitant reduction in iatrogenic complications, including OHSS
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follitropin delta + hCG | – | Drug: Follitropin deltaCombination of follitropin delta and serial hCG injections at individualized doses, where dosing regimen was determined according to AMH and weight in women undergoing an IVF antagonist cycle |
| Follitropin delta + HP-hMG | – | Drug: Follitropin deltaCombination of follitropin delta and highly-purified human menopausal gonadotropin (HP-hMG) where dosing regimen was determined according to AMH and weight in women undergoing an IVF antagonist cycle |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women consulting the clinic for fertility issues that require in vitro fertilization
Key inclusion criteria (4 listed)
- Women 18 to 42 years of age undergoing IVF/ICSI cycle
- IVF antagonist protocol
- Regular menstrual cycles of 24-35 days
- Presence of both ovaries
Key exclusion criteria (6 listed)
- Endometriosis stage III/IV
- History of recurrent miscarriages, defined as ≥ 3 consecutive losses
- Women undergoing ovarian stimulation for oncologic or elective fertility preservation
- Women participating in any other research project
- Hypersensitivity to follitropin delta and/or human chorionic gonadotropin
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 |
|---|---|---|
| Follitropin deltaEvaluation of the IVF cycle using the prescribed medication | Drug | Follitropin delta + HP-hMG, Follitropin delta + hCG |
Primary outcome
Number of good quality blastocysts
Time frame: Up to 6 day
Number of good quality oocytes fertilized
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 Dec 2025.
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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.
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 and Infertility, 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 6 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 Dec 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 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 good quality blastocysts (time frame: Up to 6 day). 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 Dec 2025.