Female Reproductive ProblemPhase 4NCT02213627
Use of Corifolitropin Alfa in Oocyte Donors
A Phase 4 study testing Corifollitropin alfa, Recombinant FSH and HP-hMG in people with Female Reproductive Problem and Infertility, run by IVI Madrid at 1 site in Spain.
Trial summary
The purpose of this study is to determine if corifollitropin alfa (long-term gonadotropin administration) is effective in a controlled ovarian stimulation protocol in oocyte donors compared to daily gonadotropin administration (recombinant FSH or HP-hMG) Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Reproductive Problem, Infertility
- What is being tested?
- Corifollitropin alfa, Recombinant FSH and HP-hMG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to Dec 2015
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-35 years who meet the entry criteria for the IVI Donor Program:
- Weight < 60 Kg
- Women with at least 6 antral follicles per ovary
- Women who will fit the protocoo during the period of the study
- Women who give written consent to participate in the test
Who cannot join
- Women with basal antral follicle count above 20 or below 6.
- Women with comorbidities, in the judgement of the investigator, that may interfere with the trearment of ovarian stimulation.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
IVI Madrid
Madrid, Madrid, 28023
Antonio Requena, MD, PhD, +34 911802900, Antonio.Requena@ivi.es
María Cruz, PhD, +34 911802900, Maria.Cruz@ivi.es
About this study
Official title: Randomized, Multicentric and Prospective Clinical Trial to Check the Cost-effectiveness of Corifollitropin Alfa vs. Recombinant FSH and/or HP-hMG
The purpose of this study is to determine if corifollitropin alfa (long-term gonadotropin administration) is effective in a controlled ovarian stimulation protocol in oocyte donors compared to daily gonadotropin administration (recombinant FSH or HP-hMG)
Read the detailed description
In recent years, increasingly advances have been developed in terms of controlled ovarian stimulation protocols. These improvements have also moved into the way of administration of the different treatments, and at present, with subcutaneous devices, it is possible to offer advantages such as the ability to ensure administration of the correct dose or modify the dose before charging.
Simplification of ovarian stimulation protocols can help to reduce physical stress of the donors and the cancellation rate. The need for daily injection does not worsen the degree of compliance, but it generates some anxiety related to the administration of the right dose and / or the possibility of making a unconsciously mistake . Innovations in delivery devices could help reduce the stress associated with the stimulation itself and improve the welfare of the donor. Given these considerations, the need to develop a stimulation protocol that reduces the physical and emotional burden of reproduction treatment is established.
Corifollitropin alfa molecule is a full-length recombinant FSH generating a sustained effect of stimulation; a single subcutaneous injection of this drug is able to replace the first seven injections of any daily FSH preparation, so finally, the result would be an overall decrease in the number of injections needed for the whole cycle. Pharmacological and pharmacodynamic characteristics of corifollitropin alfa could facilitate the design of simple stimulation protocols and the need for fewer resources when monitoring the donor, including fewer clinic visits.
- Conditions
- Female Reproductive Problem, Infertility
- Being tested
- Corifollitropin alfa, Recombinant FSH, HP-hMG
- Keywords
- Corifollitropin alfa, recombinant FSH, HP-hMG, apoptosis, oocyte donation
- 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
Also called Elonva 100 micrograms
Recombinant FSHDrug
Also called Puregon 50 IU
HP-hMGDrug
Also called Menopur 600 IU
| Study group | Role | What they receive |
|---|---|---|
| Corifollitropin alfa | Experimental | From day 2-3 of mense, a single 100 microgram dose of corifollitropin alfa is administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation. Receives: Drug: Corifollitropin alfa |
| Recombinant FSH | Experimental | From day 2-3 of mense, daily injections of 150 IU of recombinant FSH will be administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation. Receives: Drug: Recombinant FSH |
| HP-hMG | Experimental | From day 2-3 of mense, daily doses of 225 IU of HP-hMG will be administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation. Receives: Drug: HP-hMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes and mature oocytes
Measured: 3 months
Secondary outcomes (5)
Fertilization and implantation rates
Measured: 3 months
Drop-out rate and cancellation rate
Measured: 3 months
Cost-effectiveness analysis
Measured: 6 months
Endocrine profile in serum and follicular fluid
Measured: 3 months
Apoptosis rate in cumulus cells
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Reproductive ProblemStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA, Instituto Valenciano de Infertilidad, IVI Alicante
- Responsible party
- Principal investigator, Antonio Requena, IVI Madrid
- Investigators
- Antonio Requena, MD, PhD, Principal investigator, IVI MadridManuel Muñoz, MD, PhD, Study chair, Instituto Valenciano de Infertilidad, IVI AlicantePilar Alamá, MD, PhD, Study chair, IVI ValenciaMaría Cruz, PhD, Study chair, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213627
- Sponsor's protocol ID
- 1403-MAD-013-AR
- Status last verified
- Jul 2015
- First submitted
- 8 Aug 2014
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicentric and Prospective Clinical Trial to Check the Cost-effectiveness of Corifollitropin Alfa vs. Recombinant FSH and/or HP-hMG
- ClinicalTrials.gov ID
- NCT02213627
- Acronym / sponsor ID
- 1403-MAD-013-AR
- Conditions
- Female Reproductive Problem, Infertility
- Keywords
- Corifollitropin alfa, recombinant FSH, HP-hMG, apoptosis, oocyte donation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA, Instituto Valenciano de Infertilidad, IVI Alicante
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Aug 2014 (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 this study is to determine if corifollitropin alfa (long-term gonadotropin administration) is effective in a controlled ovarian stimulation protocol in oocyte donors compared to daily gonadotropin administration (recombinant FSH or HP-hMG)
Detailed description
In recent years, increasingly advances have been developed in terms of controlled ovarian stimulation protocols. These improvements have also moved into the way of administration of the different treatments, and at present, with subcutaneous devices, it is possible to offer advantages such as the ability to ensure administration of the correct dose or modify the dose before charging.
Simplification of ovarian stimulation protocols can help to reduce physical stress of the donors and the cancellation rate. The need for daily injection does not worsen the degree of compliance, but it generates some anxiety related to the administration of the right dose and / or the possibility of making a unconsciously mistake . Innovations in delivery devices could help reduce the stress associated with the stimulation itself and improve the welfare of the donor. Given these considerations, the need to develop a stimulation protocol that reduces the physical and emotional burden of reproduction treatment is established.
Corifollitropin alfa molecule is a full-length recombinant FSH generating a sustained effect of stimulation; a single subcutaneous injection of this drug is able to replace the first seven injections of any daily FSH preparation, so finally, the result would be an overall decrease in the number of injections needed for the whole cycle. Pharmacological and pharmacodynamic characteristics of corifollitropin alfa could facilitate the design of simple stimulation protocols and the need for fewer resources when monitoring the donor, including fewer clinic visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Corifollitropin alfa | Experimental | Drug: Corifollitropin alfaFrom day 2-3 of mense, a single 100 microgram dose of corifollitropin alfa is administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation. |
| Recombinant FSH | Experimental | Drug: Recombinant FSHFrom day 2-3 of mense, daily injections of 150 IU of recombinant FSH will be administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation. |
| HP-hMG | Experimental | Drug: HP-hMGFrom day 2-3 of mense, daily doses of 225 IU of HP-hMG will be administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18-35 years who meet the entry criteria for the IVI Donor Program:
- Weight < 60 Kg
- Women with at least 6 antral follicles per ovary
- Women who will fit the protocoo during the period of the study
- Women who give written consent to participate in the test
Key exclusion criteria (2 listed)
- Women with basal antral follicle count above 20 or below 6.
- Women with comorbidities, in the judgement of the investigator, that may interfere with the trearment of ovarian stimulation.
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 alfaAlso: Elonva 100 micrograms | Drug | Corifollitropin alfa |
| Recombinant FSHAlso: Puregon 50 IU | Drug | Recombinant FSH |
| HP-hMGAlso: Menopur 600 IU | Drug | HP-hMG |
Primary outcome
Number of oocytes and mature oocytes
Time frame: 3 months
5 secondary outcomes
Fertilization and implantation rates
Time frame: 3 months
Drop-out rate and cancellation rate
Time frame: 3 months
Cost-effectiveness analysis
Time frame: 6 months
Endocrine profile in serum and follicular fluid
Time frame: 3 months
Apoptosis rate in cumulus cells
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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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.
Antonio Requena, MD, PhD principal investigator
IVI Madrid
Manuel Muñoz, MD, PhD study chair
Instituto Valenciano de Infertilidad, IVI Alicante
Pilar Alamá, MD, PhD study chair
IVI Valencia
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, Recombinant FSH and HP-hMG in people with Female Reproductive Problem and Infertility, run by IVI Madrid at 1 site in Spain.
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 5 inclusion and 2 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 17 Jul 2015. 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 Spain. 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 Antonio Requena, MD, PhD (+34 911802900, Antonio.Requena@ivi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oocytes and mature oocytes (time frame: 3 months). 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 17 Jul 2015.