Infertility, FemalePhase 3Elonva_IVMNCT03197077
Optimisation of Follicular Recruitment in IVM Cycles
A Phase 3 study testing blood sampling, transvaginal ultrasound scanning and oocyte retrieval for IVM in people with Infertility, Female and Polycystic Ovary Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The study will focus on important aspects related to follicle recruitment using exogenous gonadotropins in patients with polycystic ovaries: 1. Early follicle recruitment in patients with polycystic ovaries using corifollitropin alfa: does administration of this drug result in earlier and higher FSH (follicle… Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Infertility, Female, Polycystic Ovary Syndrome
- What is being tested?
- blood sampling, transvaginal ultrasound scanning and oocyte retrieval for IVM
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2017to 31 Dec 2022
- Phase
- Phase 3
- 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 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subfertile patients between 18-36 years old eligible for ART treatment
- BMI 18-30
- Polycystic ovaries (PCO) according to the Rotterdam criteria (at least 12 antral follicles per ovary as observed on a baseline ultrasound scan), with or without hyperandrogenism, with or without oligoamenorrhoea. In other words, patients are eligible if they have PCO morphology. A diagnosis of PCOS (polycystic ovary syndrome) based on Rotterdam criteria is not compulsory.
Who cannot join
- Antral follicle count (AFC) <24
- Anti-müllerian hormone (AMH) <3,25 in non-OCP (oral contraceptive pill) users and <4,00 in current OCP users (using Elecsys platform (Roche Diagnostics))
- Couples requesting PGD (preimplantation genetic diagnosis)
- Non-obstructive azoospermia in the male partner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Corifollitropin Alfa and Recombinant FSH for Follicular Recruitment in Women With Polycystic Ovaries Who Undergo IVM Treatment
The study will focus on important aspects related to follicle recruitment using exogenous gonadotropins in patients with polycystic ovaries:
- Early follicle recruitment in patients with polycystic ovaries using corifollitropin alfa: does administration of this drug result in earlier and higher FSH (follicle stimulating hormone) concentrations above the threshold for follicle recruitment in an IVM (in vitro maturation) cycle preceded by oral contraceptive suppression, in comparison to normal daily administration of rFSH (recombinant follicle stimulating hormone, Puregon)?;
- The maturation rate of the obtained oocyte-cumulus complexes in standard IVM media registered for clinical use: does stimulation with corifollitropin alfa versus recombinant FSH have an impact on the maturation rate and developmental capacity of the oocytes ?
- Conditions
- Infertility, Female, Polycystic Ovary Syndrome
- Being tested
- blood sampling, transvaginal ultrasound scanning, oocyte retrieval for IVM, Corifollitropin Alfa, Follitropin beta
- Medical subject headings
- Infertility, Female, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingProcedure or surgery
comparison between corifollitropin alfa and follitropin beta in IVM cycles
transvaginal ultrasound scanningProcedure or surgery
comparison between corifollitropin alfa and follitropin beta in IVM cycles
oocyte retrieval for IVMProcedure or surgery
comparison between corifollitropin alfa and follitropin beta in IVM cycles
Corifollitropin AlfaDrug
Single injection of 100 micrograms of corifollitropin alfa
Follitropin betaDrug
Daily injection (three days) of follitropin beta
oral contraceptive pill pretreatment (Marvelon)Drug
Daily administration of the oral contraceptive pill (Marvelon) for 21 days. Administration of the combined oral contraceptive pill will start after a blood test that demonstrates basal E2 levels and a negative serum hCG level.
| Study group | Role | What they receive |
|---|---|---|
| Elonva | Experimental | A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection. Receives: Procedure: blood sampling; Procedure: transvaginal ultrasound scanning; Procedure: oocyte retrieval for IVM; Drug: Corifollitropin Alfa; Drug: oral contraceptive pill pretreatment (Marvelon) |
| Puregon | Active comparator | Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection. Receives: Procedure: blood sampling; Procedure: transvaginal ultrasound scanning; Procedure: oocyte retrieval for IVM; Drug: Follitropin beta; Drug: oral contraceptive pill pretreatment (Marvelon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of COC
Number of oocyte cumulus complexes obtained on the day of oocyte retrieval.
Measured: 5 days after the first gonadotropin injection (on the day of oocyte retrieval)
Secondary outcomes (1)
Clinical pregnancy rate
Clinical pregnancy rate after the first embryo transfer following the IVM cycle
Measured: At about 6 - 7 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start1 Nov 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Michel De Vos, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197077
- Sponsor's protocol ID
- 2017.corifollitropinalfa_IVM
- Acronym
- Elonva_IVM
- Status last verified
- Apr 2023
- First submitted
- 16 Jun 2017
- Last updated
- 7 Apr 2023
- 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 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Corifollitropin Alfa and Recombinant FSH for Follicular Recruitment in Women With Polycystic Ovaries Who Undergo IVM Treatment
- ClinicalTrials.gov ID
- NCT03197077
- Acronym / sponsor ID
- Elonva_IVM / 2017.corifollitropinalfa_IVM
- Conditions
- Infertility, Female, Polycystic Ovary Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Jun 2017 (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.
The study will focus on important aspects related to follicle recruitment using exogenous gonadotropins in patients with polycystic ovaries:
- Early follicle recruitment in patients with polycystic ovaries using corifollitropin alfa: does administration of this drug result in earlier and higher FSH (follicle stimulating hormone) concentrations above the threshold for follicle recruitment in an IVM (in vitro maturation) cycle preceded by oral contraceptive suppression, in comparison to normal daily administration of rFSH (recombinant follicle stimulating hormone, Puregon)?;
- The maturation rate of the obtained oocyte-cumulus complexes in standard IVM media registered for clinical use: does stimulation with corifollitropin alfa versus recombinant FSH have an impact on the maturation rate and developmental capacity of the oocytes ?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elonva | Experimental | Procedure: blood sampling, Procedure: transvaginal ultrasound scanning, Procedure: oocyte retrieval for IVM, Drug: Corifollitropin Alfa, Drug: oral contraceptive pill pretreatment (Marvelon)A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection. |
| Puregon | Active comparator | Procedure: blood sampling, Procedure: transvaginal ultrasound scanning, Procedure: oocyte retrieval for IVM, Drug: Follitropin beta, Drug: oral contraceptive pill pretreatment (Marvelon)Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subfertile patients between 18-36 years old eligible for ART treatment
- BMI 18-30
- Polycystic ovaries (PCO) according to the Rotterdam criteria (at least 12 antral follicles per ovary as observed on a baseline ultrasound scan), with or without hyperandrogenism, with or without oligoamenorrhoea. In other words, patients are eligible if they have PCO morphology. A diagnosis of PCOS (polycystic ovary syndrome) based on Rotterdam criteria is not compulsory.
Key exclusion criteria (4 listed)
- Antral follicle count (AFC) <24
- Anti-müllerian hormone (AMH) <3,25 in non-OCP (oral contraceptive pill) users and <4,00 in current OCP users (using Elecsys platform (Roche Diagnostics))
- Couples requesting PGD (preimplantation genetic diagnosis)
- Non-obstructive azoospermia in the male partner
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 |
|---|---|---|
| blood samplingcomparison between corifollitropin alfa and follitropin beta in IVM cycles | Procedure or surgery | Elonva, Puregon |
| transvaginal ultrasound scanningcomparison between corifollitropin alfa and follitropin beta in IVM cycles | Procedure or surgery | Elonva, Puregon |
| oocyte retrieval for IVMcomparison between corifollitropin alfa and follitropin beta in IVM cycles | Procedure or surgery | Elonva, Puregon |
| Corifollitropin AlfaSingle injection of 100 micrograms of corifollitropin alfa | Drug | Elonva |
| Follitropin betaDaily injection (three days) of follitropin beta | Drug | Puregon |
| oral contraceptive pill pretreatment (Marvelon)Daily administration of the oral contraceptive pill (Marvelon) for 21 days. Administration of the combined oral contraceptive pill will start after a blood test that demonstrates basal E2 levels and a negative serum hCG level. | Drug | Elonva, Puregon |
Primary outcome
Number of COC
Time frame: 5 days after the first gonadotropin injection (on the day of oocyte retrieval)
Number of oocyte cumulus complexes obtained on the day of oocyte retrieval.
1 secondary outcome
Clinical pregnancy rate
Time frame: At about 6 - 7 weeks gestation
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 7 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing blood sampling, transvaginal ultrasound scanning and oocyte retrieval for IVM in people with Infertility, Female and Polycystic Ovary Syndrome, run by Universitair Ziekenhuis Brussel 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 3 inclusion and 4 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 7 Apr 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 COC (time frame: 5 days after the first gonadotropin injection (on the day of oocyte retrieval)). 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 7 Apr 2023.