InfertilityNCT05737979
Modified Rekovelle and Menopur Combination Protocol to Avoid Monitoring Before Day 10 of Stimulation
An observational study of Infertility and IVF, run by Clinique Ovo at 1 site in Canada.
Trial summary
Follitropin delta (Rekovelle) algorithm established by Ferring provides personalized gonadotrophin doses based on each patient's weight and AMH. As a result, risks of stimulation failure or ovarian hyperstimulation syndrome (OHSS) during an in vitro fertilization (IVF) cycle are minimized. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility, IVF
- What is being tested?
- Study chart review
- How many people
- 772 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jan 2023to 27 Jan 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 years and older
- Women only
- Adult, Older adult
Study population: Women consulting the clinic for fertility issues that require in vitro fertilization
Who may be able to join
- Women of 18 years of age or older having provided consent to chart access for scientific publication in the IVF consent form
- Antagonist IVF cycle using combination of Rekovelle and Menopur for stimulation according to the modified protocol employed at clinique ovo without deviation
- Presence of both ovaries
Who cannot join
- Second cycle of Duo-Stim IVF
Trial locations and contacts
1 site in 1 country.
About this study
Follitropin delta (Rekovelle) algorithm established by Ferring provides personalized gonadotrophin doses based on each patient's weight and AMH. As a result, risks of stimulation failure or ovarian hyperstimulation syndrome (OHSS) during an in vitro fertilization (IVF) cycle are minimized.
As a standard practice for OHSS prevention at clinique ovo, women undergoing IVF will have a scheduled ultrasound and blood test on the sixth day of their stimulation treatment. However, with the determination of the Rekovelle and Menopur algorithm, the risks of OHSS before the tenth day have been considerably minimized.
Read the detailed description
The purpose of this study is to evaluate the necessity of programming an ultrasound and blood test prior to the tenth day of ovarian stimulation when women are on personalized doses of Rekovelle and Menopur duting an antagonist IVF cycle. Based on the results of the analysis, we will assess the economic impact that programming an ultrasound and blood test at day 10 might have.
- Conditions
- Infertility, IVF
- Being tested
- Study chart review
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study chart reviewOther
Evaluation of the IVF cycle using the prescribed medication
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing IVF | Women undergoing an antagonist in vitro fertilization cycle using Rekovelle and Menopur for stimulation Receives: Other: Study chart review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the population where a simplified IVF monitoring is conceivable
Rate of Rekovelle and / or Menopur dose modification before day 10 ultrasound
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start27 Jan 2023
- Primary completion30 Nov 2023
- Study completion27 Jan 2024
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
- Retrospective
- Enrolment
- 772 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
- NCT05737979
- Sponsor's protocol ID
- 3189
- Status last verified
- Feb 2024
- First submitted
- 10 Feb 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Rekovelle and Menopur Combination Protocol to Avoid Monitoring Before Day 10 of Stimulation
- ClinicalTrials.gov ID
- NCT05737979
- Acronym / sponsor ID
- 3189
- Conditions
- Infertility, IVF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 772 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 27 Jan 2024 (actual)
- First posted
- 21 Feb 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 (Rekovelle) algorithm established by Ferring provides personalized gonadotrophin doses based on each patient's weight and AMH. As a result, risks of stimulation failure or ovarian hyperstimulation syndrome (OHSS) during an in vitro fertilization (IVF) cycle are minimized.
As a standard practice for OHSS prevention at clinique ovo, women undergoing IVF will have a scheduled ultrasound and blood test on the sixth day of their stimulation treatment. However, with the determination of the Rekovelle and Menopur algorithm, the risks of OHSS before the tenth day have been considerably minimized.
Detailed description
The purpose of this study is to evaluate the necessity of programming an ultrasound and blood test prior to the tenth day of ovarian stimulation when women are on personalized doses of Rekovelle and Menopur duting an antagonist IVF cycle. Based on the results of the analysis, we will assess the economic impact that programming an ultrasound and blood test at day 10 might have.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing IVF | – | Other: Study chart reviewWomen undergoing an antagonist in vitro fertilization cycle using Rekovelle and Menopur for stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women consulting the clinic for fertility issues that require in vitro fertilization
Key inclusion criteria (3 listed)
- Women of 18 years of age or older having provided consent to chart access for scientific publication in the IVF consent form
- Antagonist IVF cycle using combination of Rekovelle and Menopur for stimulation according to the modified protocol employed at clinique ovo without deviation
- Presence of both ovaries
Key exclusion criteria (1 listed)
- Second cycle of Duo-Stim IVF
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 |
|---|---|---|
| Study chart reviewEvaluation of the IVF cycle using the prescribed medication | Other | Women undergoing IVF |
Primary outcome
Identify the population where a simplified IVF monitoring is conceivable
Time frame: Up to 3 weeks
Rate of Rekovelle and / or Menopur dose modification before day 10 ultrasound
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 20 Feb 2024.
- 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.
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 Infertility and IVF, 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 3 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 20 Feb 2024. 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?
Identify the population where a simplified IVF monitoring is conceivable (time frame: Up to 3 weeks). 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 20 Feb 2024.