Testing Combination therapy : Follitropin delta for IVF
Official title: Menopur And Rekovelle Combination Study Version 2.0
- Phase 2
- 1 group
- Sites in Ottawa and Montreal
- Recruiting
Interventions
- Medication
Combination therapy : Follitropin delta and HP-hMG
Follitropin delta dose will be determined by age. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight.
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
Ottawa fertility centre
Ottawa, Ontario
- Recruiting
Clinique ovo
Montreal, Quebec
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Women aged 18 to 40 years inclusively at the time of consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more → signature
- +Regular menstrual cycles of 24-35 days
- +Diagnosis of unexplained infertility, tubal infertility, endometriosis stage I/II or male factor infertility
- +Presence of both ovaries
- +Early follicular phase FSH serum concentration \<10 IU/L measured between Day 2 and Day 5 of menstrual cycle within the previous 24 months
- +First IVF/ICSI cycle
- +IVF antagonist protocolProtocolThe detailed plan a study must follow.Read more → prescribed
- +Partner or donor ejaculated sperm (fresh or frozen) used for fertilization
Exclusion
- −Hypersensitivity to any active ingredient or excipients in follitropin delta and/or HP-hMG
- −Women undergoing oocyte donation
- −Endometriosis stage III/IV
- −High risk of OHSS (AMH ≥ 35 pmol/L)
- −Body Mass Index (BMI) \> 40 kg/m2 ProtocolProtocolThe detailed plan a study must follow.Read more → number: IIS-1056 MARCS 2.0 Study Version: 1.1 - Date : 14 APR 2025 Page 12 of 28
- −Gynaecological haemorrhages of unknown aetiology
- −History of recurrent miscarriages defined as ≥ 3 consecutive losses
- −Renal or hepatic impairment
- −Tumours of hypothalamus or pituitary gland
- −Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
- −Current or history of ovarian, uterine or mammary carcinoma
- −History of thrombophilia
- −Use of hormonal preparations (except for 17β-estradiol, testosterone gel, DHEA and thyroid medication) during the last menstrual cycle
- −Women participating in any other interventionalInterventional studyA study where participants are given something to see what happens.Read more → research project
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Combination therapy : Follitropin delta and HP-hMG.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 40 years.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 200 people.
The study is currently expected to finish around August 2027.
The main measurement is taken over: 5 to 6 days after egg retrieval (up to 1 to 2 months after enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
number of good quality (>3BB) or utilizable blastocysts per treatment cycle at day 5 or 6 of embryo culture — measured over 5 to 6 days after egg retrieval (up to 1 to 2 months after enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06997900 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Combination therapy : Follitropin delta and HP-hMGDrug
Follitropin delta dose will be determined by age. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 40 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 40 years.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 5 to 6 days after egg retrieval (up to 1 to 2 months after enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →).
The study as a whole is currently expected to finish around 2027-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 200 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Ottawa, Ontario, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of this clinical trial is to evaluate the safety and effectiveness of a personalized ovarian stimulation regimen in women aged 18 to 40 undergoing in vitro fertilization (IVF). The main question it aims to answer is: \- Does personalizing the starting doses of follitropin delta (REKOVELLE) and HP-hMG (MENOPUR) based on both age and body lead to similar results as anti-Müllerian hormone (AMH) and weight based dosing ? Researchers will compare the new dosing regimen to the MARCS study results to see if this new approach leads to similar outcomes Participants will: * Receive ovarian stimulation using a personalized dose of REKOVELLE aND MENOPUR based on age and weight * Be monitored through ultrasound imaging and blood tests to measure estradiol (E2) levels * Undergo standard IVF procedures including egg retrieval and embryo assessment
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Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.