Ovarian ReservePhase 4MONACONCT04487925
Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders
A Phase 4 study testing A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation and Up to three modified natural cycles with Follitropin beta. in people with Ovarian Reserve and Poor Responders, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This is a prospective, randomized, single center, phase 4 controlled trial. The study will compare the efficacy of two different strategies for the management of predicted poor response patients under stimulation for IVF/ICSI: up to three MNC cycles (group 1) versus a single GnRH antagonist CFA (group 2). Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Ovarian Reserve, Poor Responders, IVF
- What is being tested?
- A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation and Up to three modified natural cycles with Follitropin beta.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jan 2022to 31 Dec 2024
- Phase
- Phase 4
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent form (ICF) dated and signed.
- Age ≥18 and <45 years old.
- Body Mass Index (BMI) ≥18.5 Kg/m² and <35 Kg/m².
- Regular menstrual cycles (between 21 and 35 days).
- Two ovaries present.
- Current pregnancy wish.
- Poor responders as defined according to the POSEIDON criteria:
- POSEIDON Group 3: patients < 35 years with poor ovarian reserve pre-stimulation parameters (AFC <5 or AMH <1.2 ng/mL); POSEIDON Group 4: patients ≥35 years with poor ovarian reserve pre-stimulation parameters (AFC <5 or AMH <1.2 ng/mL).
Who cannot join
- Simultaneous participation in another clinical study.
- Untreated and uncontrolled thyroid dysfunction.
- Tumors of the ovary, breast, uterus, pituitary or hypothalamus.
- Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
- Ovarian cysts or enlarged ovaries.
- Malformations of the reproductive organs.
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- Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy.
- Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin).
- Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent, 9000
Dominic Stoop, dominic.stoop@uzgent.be
Rebecca De Beir, rebecca.debeir@uzgent.be
About this study
Official title: A Randomized Comparison of One Controlled Ovarian Stimulation With Corifollitropin Alfa Versus up to Three Modified Natural Cycles in Expected and Established Poor Responders
This is a prospective, randomized, single center, phase 4 controlled trial. The study will compare the efficacy of two different strategies for the management of predicted poor response patients under stimulation for IVF/ICSI: up to three MNC cycles (group 1) versus a single GnRH antagonist CFA (group 2).
- Conditions
- Ovarian Reserve, Poor Responders, IVF
- Being tested
- A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation, Up to three modified natural cycles with Follitropin beta.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulationDrug
CFA will be administered in combination with Follitropin beta.
Up to three modified natural cycles with Follitropin beta.Drug
Follitropin beta in a low dose will be given.
| Study group | Role | What they receive |
|---|---|---|
| Up to 3 modified natural cycles | Active comparator | Not described Receives: Drug: Up to three modified natural cycles with Follitropin beta. |
| Controlled ovarian stimulation | Experimental | Not described Receives: Drug: A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of good quality blastocysts after CFA stimulation vs. after a first MNC
Measured: On fifth day of embryonal development
Secondary outcomes (3)
Number of good quality blastocysts after CFA stimulation vs. after a second or third MNC
Measured: On fifth day of embryonal development
The relative number of blastocysts after ART, relative to the number of oocytes
Measured: On fifth day of embryonal development
The probability of having at least one blastocyst of good quality after ART
Measured: On fifth day of embryonal development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start25 Jan 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian ReserveStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominic Stoop, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487925
- Sponsor's protocol ID
- BC-09933
- Acronym
- MONACO
- Status last verified
- May 2024
- First submitted
- 22 Jul 2020
- Last updated
- 9 May 2024
- Results posted
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of One Controlled Ovarian Stimulation With Corifollitropin Alfa Versus up to Three Modified Natural Cycles in Expected and Established Poor Responders
- ClinicalTrials.gov ID
- NCT04487925
- Acronym / sponsor ID
- MONACO / BC-09933
- Conditions
- Ovarian Reserve, Poor Responders, IVF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jul 2020 (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 is a prospective, randomized, single center, phase 4 controlled trial. The study will compare the efficacy of two different strategies for the management of predicted poor response patients under stimulation for IVF/ICSI: up to three MNC cycles (group 1) versus a single GnRH antagonist CFA (group 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Up to 3 modified natural cycles | Active comparator | Drug: Up to three modified natural cycles with Follitropin beta. |
| Controlled ovarian stimulation | Experimental | Drug: A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Informed consent form (ICF) dated and signed.
- Age ≥18 and <45 years old.
- Body Mass Index (BMI) ≥18.5 Kg/m² and <35 Kg/m².
- Regular menstrual cycles (between 21 and 35 days).
- Two ovaries present.
Key exclusion criteria (9 listed)
- Simultaneous participation in another clinical study.
- Untreated and uncontrolled thyroid dysfunction.
- Tumors of the ovary, breast, uterus, pituitary or hypothalamus.
- Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
- Ovarian cysts or enlarged ovaries.
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 |
|---|---|---|
| A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulationCFA will be administered in combination with Follitropin beta. | Drug | Controlled ovarian stimulation |
| Up to three modified natural cycles with Follitropin beta.Follitropin beta in a low dose will be given. | Drug | Up to 3 modified natural cycles |
Primary outcome
Number of good quality blastocysts after CFA stimulation vs. after a first MNC
Time frame: On fifth day of embryonal development
3 secondary outcomes
Number of good quality blastocysts after CFA stimulation vs. after a second or third MNC
Time frame: On fifth day of embryonal development
The relative number of blastocysts after ART, relative to the number of oocytes
Time frame: On fifth day of embryonal development
The probability of having at least one blastocyst of good quality after ART
Time frame: On fifth day of embryonal development
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 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.
Dominic Stoop, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation and Up to three modified natural cycles with Follitropin beta. in people with Ovarian Reserve and Poor Responders, run by University Hospital, Ghent at 1 site in Belgium.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 May 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Somers, MSc (0032 9 332 30 48, studieco.vrouwenkliniek@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of good quality blastocysts after CFA stimulation vs. after a first MNC (time frame: On fifth day of embryonal development). 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 May 2024.