Fertility DisordersMARCSNCT03483545
Menopur And Rekovelle Combination Study
A study testing Follitropin delta and HP-hMG in people with Fertility Disorders, run by Dr François Bissonnette at 4 sites in Canada.
Trial summary
This study proposes to evaluate the effect of adding HP-hMG (Menopur) to follitropin delta in a "mixed protocol" regimen, using an individualized, fixed dose of follitropin delta based on the established algorithm, combined with a variable, adjustable dose of Menopur based on body weight and ovarian reserve. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- Follitropin delta and HP-hMG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesCanada
- Study dates
- 17 Jul 2018to 31 Jul 2019
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women 18 to 40 years of age undergoing their first IVF/ICSI cycle
- Diagnosed with unexplained infertility, tubal infertility, endometriosis stage I/II, or with partners diagnosed with male factor infertility
- Regular menstrual cycles of 24-35 days
- Presence of both ovaries
- Early follicular phase FSH serum concentration <10 IU/L measured between Day 2 to Day 5 of menstrual cycle within the previous 12 months
- Ejaculated sperm (fresh or frozen) for insemination
Who cannot join
- Inability to consent
- Endometriosis stage III and IV
- High risk of OHSS (AMH ≥ 35 pmol/L)
- History of recurrent miscarriages defined as ≥ 3 consecutive losses
- Women undergoing egg donation
- Women participating in any other research project
- Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle
- Hypersensitivity to follitropin delta and/or HP-hMG
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Clinique Ovo
Montreal, Quebec, H4P 2S4
Hannam Fertility Centre
Toronto, Ontario, M4W 3R2
CReATe Fertility Centre
Toronto, Ontario, M5G 1N8
Olive Fertility Centre
Vancouver, British Columbia, V5Z 3X7
About this study
Official title: An Exploratory Study to Evaluate a Mixed Protocol of Menopur (Highly Purified Human Menopausal Gonadotropin) and REKOVELLE (Follitropin Delta) for Controlled Ovarian Stimulation in IVF (in Vitro Fertilization)
This study proposes to evaluate the effect of adding HP-hMG (Menopur) to follitropin delta in a "mixed protocol" regimen, using an individualized, fixed dose of follitropin delta based on the established algorithm, combined with a variable, adjustable dose of Menopur based on body weight and ovarian reserve.
Read the detailed description
The initial dose of follitropin delta will be determined at enrolment by the analysis of serum AMH on days 2 to 5 of the menstrual cycle preceding the IVF treatment cycle and body weight in Kg The initial dose of HP-hMG to be added on top of follitropin delta will be determined at enrolment by the total follitropin delta dose and body weight in Kg
- Conditions
- Fertility Disorders
- Being tested
- Follitropin delta and HP-hMG
- Keywords
- Ovarian Response, In vitro fertilization, Controlled ovarian stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin delta and HP-hMGCombination product
Follitropin delta dose will be determined by AMG and weight in Kg. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight in Kg
| Study group | Role | What they receive |
|---|---|---|
| Follitropin delta and HP-hMG | Experimental | Follitropin delta combined with highly purified human menopausal gonadotrophin Receives: Combination Product: Follitropin delta and HP-hMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the number of utilizable blastocysts on Day 5 or Day 6 of embryo culture
Utilizable blastocyst is defined as embryo at day 5 or 6 suitable for transfer
Measured: 6 days of embryo culture
Secondary outcomes (2)
Determine dosage of REKOVELLE and Menopur in a mixed protocol
Evaluate the effect of adding HP-hMG (Menopur) to follitropin delta (REKOVELLE) during IVF stimulation
Measured: up to 20 days
Evaluate the safety profile of the REKOVELLE - Menopur mixed protocol algorithm
The safety profile is the proportion of women with early and late OHSS and/or preventive interventions for early OHSS (i.e., triggering with GnRH agonist, use of dopamine agonist, conversion of planned fresh transfer into a freeze-all). OHSS is defined as an iatrogenic complication that occurs mainly due to ovarian overstimulation by gonadotropins.
Measured: up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start17 Jul 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fertility DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr François Bissonnette
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Create Fertility Center, Olive Fertility Centre, Hannam Fertility Centre
- Responsible party
- Sponsor-investigator, Dr François Bissonnette, Clinique Ovo
- Investigators
- François Bissonnette, MD, Principal investigator, Clinique OvoClifford Librach, MD, Principal investigator, CReATe Fertility CentreTom Hannam, MD, Principal investigator, Hannam Fertility CentreAl Yuzpe, MD, Principal investigator, Olive Fertility Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483545
- Sponsor's protocol ID
- 000324
- Acronym
- MARCS
- Status last verified
- Aug 2019
- First submitted
- 8 Mar 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bissonnette F, Minano Masip J, Kadoch IJ, Librach C, Sampalis J, Yuzpe A. Individualized ovarian stimulation for in vitro fertilization: a multicenter, open label, exploratory study with a mixed protocol of follitropin delta and highly purified human menopausal gonadotropin. Fertil Steril. 2021 Apr;115(4):991-1000. doi: 10.1016/j.fertnstert.2020.09.158. Epub 2020 Nov 30.
PubMed 33267959
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate a Mixed Protocol of Menopur (Highly Purified Human Menopausal Gonadotropin) and REKOVELLE (Follitropin Delta) for Controlled Ovarian Stimulation in IVF (in Vitro Fertilization)
- ClinicalTrials.gov ID
- NCT03483545
- Acronym / sponsor ID
- MARCS / 000324
- Conditions
- Fertility Disorders
- Keywords
- Ovarian Response, In vitro fertilization, Controlled ovarian stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Dr François BissonnetteIndustry (pharma, biotech, devices)
- Collaborators
- Create Fertility Center, Olive Fertility Centre, Hannam Fertility Centre
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 30 Mar 2018 (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.
This study proposes to evaluate the effect of adding HP-hMG (Menopur) to follitropin delta in a "mixed protocol" regimen, using an individualized, fixed dose of follitropin delta based on the established algorithm, combined with a variable, adjustable dose of Menopur based on body weight and ovarian reserve.
Detailed description
The initial dose of follitropin delta will be determined at enrolment by the analysis of serum AMH on days 2 to 5 of the menstrual cycle preceding the IVF treatment cycle and body weight in Kg The initial dose of HP-hMG to be added on top of follitropin delta will be determined at enrolment by the total follitropin delta dose and body weight in Kg
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follitropin delta and HP-hMG | Experimental | Combination Product: Follitropin delta and HP-hMGFollitropin delta combined with highly purified human menopausal gonadotrophin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women 18 to 40 years of age undergoing their first IVF/ICSI cycle
- Diagnosed with unexplained infertility, tubal infertility, endometriosis stage I/II, or with partners diagnosed with male factor infertility
- Regular menstrual cycles of 24-35 days
- Presence of both ovaries
- Early follicular phase FSH serum concentration <10 IU/L measured between Day 2 to Day 5 of menstrual cycle within the previous 12 months
Key exclusion criteria (8 listed)
- Inability to consent
- Endometriosis stage III and IV
- High risk of OHSS (AMH ≥ 35 pmol/L)
- History of recurrent miscarriages defined as ≥ 3 consecutive losses
- Women undergoing egg donation
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 delta and HP-hMGFollitropin delta dose will be determined by AMG and weight in Kg. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight in Kg | Combination product | Follitropin delta and HP-hMG |
Primary outcome
Evaluate the number of utilizable blastocysts on Day 5 or Day 6 of embryo culture
Time frame: 6 days of embryo culture
Utilizable blastocyst is defined as embryo at day 5 or 6 suitable for transfer
2 secondary outcomes
Determine dosage of REKOVELLE and Menopur in a mixed protocol
Time frame: up to 20 days
Evaluate the safety profile of the REKOVELLE - Menopur mixed protocol algorithm
Time frame: up to 20 days
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 28 Aug 2019.
- Derived from this study: PubMed 33267959Bissonnette F, Minano Masip J, Kadoch IJ, Librach C, Sampalis J, Yuzpe A. Individualized ovarian stimulation for in vitro fertilization: a multicenter, open label, exploratory study with a mixed protocol of follitropin delta and highly purified human menopausal gonadotropin. Fertil Steril. 2021 Apr;115(4):991-1000. doi: 10.1016/j.fertnstert.2020.09.158. Epub 2020 Nov 30.
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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.
François Bissonnette, MD principal investigator
Clinique Ovo
Clifford Librach, MD principal investigator
CReATe Fertility Centre
Tom Hannam, MD principal investigator
Hannam Fertility Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follitropin delta and HP-hMG in people with Fertility Disorders, run by Dr François Bissonnette at 4 sites 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 6 inclusion and 8 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Evaluate the number of utilizable blastocysts on Day 5 or Day 6 of embryo culture (time frame: 6 days of embryo culture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03483545, which also lists 1 linked publication.
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 28 Aug 2019.