InfertilityPhase 4NCT01633580
D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists
A Phase 4 study testing corifollitropin alfa in people with Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The purpose of the present study is to analyse if corifollitropin alfa, an agent for prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day 2 onwards for a controlled ovarian hyperstimulation (COH) in an antagonist protocol. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- corifollitropin alfa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2011to Mar 2013
- 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 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- < 36 years old on day of randomisation
- FSH < 12 (in the early follicular phase)
- Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
- Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
- BMI ≤ 29
- Weight > 60 kg
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- < 3 previous trials
- ICSI
- Randomisation at out-patient clinic
Who cannot join
- ≥ 36 years old on day of randomisation
- Endometriosis ≥ grade 3
- PCOS
- Poor responders (development of < 4 follicles in a previous IVF/ICSI cycle)
- Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follicular Phase Endocrine Characteristics During Ovarian Stimulation and GnRH Antagonist Co-treatment for IVF; Randomized Trial Comparing Corifollitropin Alfa (Elonva) Initiated on Cycle Day 2 or 4.
The purpose of the present study is to analyse if corifollitropin alfa, an agent for prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day 2 onwards for a controlled ovarian hyperstimulation (COH) in an antagonist protocol.
Read the detailed description
Corifollitropin alfa is a new recombinant gonadotrophin with sustained follicle-stimulating activity. It offers novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF or in vitro fertilisation resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. Normally, this medication is started on day 2 of the cycle. In the present randomised trial, we want to evaluate whether this agent can be clinically used when started on day 4 of the cycle.
- Conditions
- Infertility
- Being tested
- corifollitropin alfa
- Keywords
- ICSI, GnRH antagonist, corifollitropin alfa
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corifollitropin alfaDrug
long acting FSH
| Study group | Role | What they receive |
|---|---|---|
| Day 2 group | Placebo comparator | Patients undergo a standard treatment with a classical start of corifollitropin alfa in a GnRH antagonist protocol. Receives: Drug: corifollitropin alfa |
| Day 4 group | Active comparator | Patients undergo an ovarian stimulation, but start on day 4 with corifollitropin alfa Receives: Drug: corifollitropin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of rFSH at the end of the follicular phase
The purpose is to assess the additional need for recFSH in each treatment group
Measured: up to 9 months
Secondary outcomes (1)
Pregnancy rate
The purpose is to study the pregnancy rate in each treatment group
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionMar 2013
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 InfertilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blockeel Christophe, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633580
- Sponsor's protocol ID
- 2012/019
- Status last verified
- Dec 2014
- First submitted
- 29 Jun 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Blockeel C, Polyzos NP, Derksen L, De Brucker M, Vloeberghs V, van de Vijver A, De Vos M, Tournaye H. Administration of corifollitropin alfa on Day 2 versus Day 4 of the cycle in a GnRH antagonist protocol: a randomized controlled pilot study. Hum Reprod. 2014 Jul;29(7):1500-7. doi: 10.1093/humrep/deu105. Epub 2014 May 9.
PubMed 24813196
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Phase Endocrine Characteristics During Ovarian Stimulation and GnRH Antagonist Co-treatment for IVF; Randomized Trial Comparing Corifollitropin Alfa (Elonva) Initiated on Cycle Day 2 or 4.
- ClinicalTrials.gov ID
- NCT01633580
- Acronym / sponsor ID
- 2012/019
- Conditions
- Infertility
- Keywords
- ICSI, GnRH antagonist, corifollitropin alfa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Jul 2012 (estimated)
- 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 purpose of the present study is to analyse if corifollitropin alfa, an agent for prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day 2 onwards for a controlled ovarian hyperstimulation (COH) in an antagonist protocol.
Detailed description
Corifollitropin alfa is a new recombinant gonadotrophin with sustained follicle-stimulating activity. It offers novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF or in vitro fertilisation resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. Normally, this medication is started on day 2 of the cycle. In the present randomised trial, we want to evaluate whether this agent can be clinically used when started on day 4 of the cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day 2 group | Placebo comparator | Drug: corifollitropin alfaPatients undergo a standard treatment with a classical start of corifollitropin alfa in a GnRH antagonist protocol. |
| Day 4 group | Active comparator | Drug: corifollitropin alfaPatients undergo an ovarian stimulation, but start on day 4 with corifollitropin alfa |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- < 36 years old on day of randomisation
- FSH < 12 (in the early follicular phase)
- Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
- Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
- BMI ≤ 29
Key exclusion criteria (5 listed)
- ≥ 36 years old on day of randomisation
- Endometriosis ≥ grade 3
- PCOS
- Poor responders (development of < 4 follicles in a previous IVF/ICSI cycle)
- Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
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 |
|---|---|---|
| corifollitropin alfalong acting FSH | Drug | Day 2 group, Day 4 group |
Primary outcome
Consumption of rFSH at the end of the follicular phase
Time frame: up to 9 months
The purpose is to assess the additional need for recFSH in each treatment group
1 secondary outcome
Pregnancy rate
Time frame: Up to 9 months
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 3 Dec 2014.
- Derived from this study: PubMed 24813196Blockeel C, Polyzos NP, Derksen L, De Brucker M, Vloeberghs V, van de Vijver A, De Vos M, Tournaye H. Administration of corifollitropin alfa on Day 2 versus Day 4 of the cycle in a GnRH antagonist protocol: a randomized controlled pilot study. Hum Reprod. 2014 Jul;29(7):1500-7. doi: 10.1093/humrep/deu105. Epub 2014 May 9.
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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 4 study testing corifollitropin alfa in people with Infertility, 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 9 inclusion and 5 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 3 Dec 2014. 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. Some participants in this study may receive a placebo. 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?
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?
Consumption of rFSH at the end of the follicular phase (time frame: up to 9 months). 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 NCT01633580, 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 3 Dec 2014.