Oocyte DonationPhase 4NCT02490150
Corifollitropin Alfa on D5 Versus D7 After Contraceptive Pill
A Phase 4 study testing Corifollitropin alfa in people with Oocyte Donation, run by Fundacion Dexeus at 1 site in Spain.
Trial summary
To evaluate if the administration of corifollitropin alfa on day 7 instead of on day 5 after pre-treatment with oral contraceptive pill results in a reduced total rFSH (recombinant follicle stimulating hormone ) consumption in a GnRH antagonist protocol in donors. 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
- Oocyte Donation
- What is being tested?
- Corifollitropin alfa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2015to Jun 2016
- 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 18-35 y old ,with regular spontaneous menstrual cycles of 25-30 days length
- Who had vaginal sexual intercourse or have no inconvenient for vaginal explorations
- Donors can´t have more than 6 children (neither own or after donations)
- Not be adopted or being born after a gamete donation pregnancy
- BMI between 18-28 kg/m2
- Height > 1.55cm
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- Gynecological and general examination with Pap smear, HIV, HCV (hepatitis C virus ), HBV (hepatitis B virus ) and RPR(rapid plasma reagin test ) negative serology, and with normal karyotype
- No abnormal Psychological profile
- Discard any disease: blood disorders, neurodegenerative/psychiatric diseases, Fragile X Syndrome, cystic fibrosis carrier, oncology diseases.
- Without psychological/psychiatric family history
- Will conform to the protocol for the duration of the study
- Willingness of adhesion to protocol during the whole study period
- Signed informed consent
Who cannot join
- Polycystic ovarian syndrome
- Antral follicle count > 20
- Hypersensitivity to the active substance or any of the excipients
- Abnormal vaginal bleeding of unknown ethiology
- Presence of ovarian cysts or increased size ovaries
- History of ovarian hyperstimulation syndrome
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- Previous controlled ovarian stimulation cycle with more than 30 follicles ≥ 11mm
- Previous abdominal surgery that contraindicated the practice of follicular puncture
- HIV, HCV, HBV positive serology in women or partner
- Important systemic diseases that could interfere with gonadotrophin treatment (ovarian and hypothalamic tumors…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Administration of Corifollitropin Alfa on Day 5 Versus Day 7 After Last Oral Contraceptive Pill in a GnRH (Gonadotropin-releasing Hormone ) Antagonist Protocol in Donors
To evaluate if the administration of corifollitropin alfa on day 7 instead of on day 5 after pre-treatment with oral contraceptive pill results in a reduced total rFSH (recombinant follicle stimulating hormone ) consumption in a GnRH antagonist protocol in donors.
- Conditions
- Oocyte Donation
- Being tested
- Corifollitropin alfa
- Keywords
- Corifollitropin alfa, Stimulation protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corifollitropin alfaDrug
| Study group | Role | What they receive |
|---|---|---|
| Day 5 | Experimental | Administration of corifollitropin alfa on Day 5 after last oral contraceptive pill in a GnRH antagonist protocol in donors. Receives: Drug: Corifollitropin alfa |
| Day 7 | Active comparator | Administration of corifollitropin alfa on Day 7 after last oral contraceptive pill in a GnRH antagonist protocol in donors. Receives: Drug: Corifollitropin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
total dosis of rFSH (IU)
Measured: donors will be followed until the end of stimulation period, an expected average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2016
- Study completionJun 2016
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 Oocyte DonationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Collaborators
- Francisca Martínez, Buenaventura Coroleu, Elisabet Clua, Ignacio Rodríguez
- Responsible party
- Principal investigator, Ignacio Rodriguez, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490150
- Sponsor's protocol ID
- HDQ-COR-2014-01
- Status last verified
- May 2017
- First submitted
- 22 Jun 2015
- Last updated
- 16 May 2017
- 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 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Corifollitropin Alfa on Day 5 Versus Day 7 After Last Oral Contraceptive Pill in a GnRH (Gonadotropin-releasing Hormone ) Antagonist Protocol in Donors
- ClinicalTrials.gov ID
- NCT02490150
- Acronym / sponsor ID
- HDQ-COR-2014-01
- Conditions
- Oocyte Donation
- Keywords
- Corifollitropin alfa, Stimulation protocol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Collaborators
- Francisca Martínez, Buenaventura Coroleu, Elisabet Clua, Ignacio Rodríguez
- Study start
- Feb 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Jul 2015 (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.
To evaluate if the administration of corifollitropin alfa on day 7 instead of on day 5 after pre-treatment with oral contraceptive pill results in a reduced total rFSH (recombinant follicle stimulating hormone ) consumption in a GnRH antagonist protocol in donors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day 5 | Experimental | Drug: Corifollitropin alfaAdministration of corifollitropin alfa on Day 5 after last oral contraceptive pill in a GnRH antagonist protocol in donors. |
| Day 7 | Active comparator | Drug: Corifollitropin alfaAdministration of corifollitropin alfa on Day 7 after last oral contraceptive pill in a GnRH antagonist protocol in donors. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Women 18-35 y old ,with regular spontaneous menstrual cycles of 25-30 days length
- Who had vaginal sexual intercourse or have no inconvenient for vaginal explorations
- Donors can´t have more than 6 children (neither own or after donations)
- Not be adopted or being born after a gamete donation pregnancy
- BMI between 18-28 kg/m2
Key exclusion criteria (10 listed)
- Polycystic ovarian syndrome
- Antral follicle count > 20
- Hypersensitivity to the active substance or any of the excipients
- Abnormal vaginal bleeding of unknown ethiology
- Presence of ovarian cysts or increased size 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 |
|---|---|---|
| Corifollitropin alfa | Drug | Day 5, Day 7 |
Primary outcome
total dosis of rFSH (IU)
Time frame: donors will be followed until the end of stimulation period, an expected average of 15 days
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 16 May 2017.
- Background: 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 Oocyte Donation, run by Fundacion Dexeus 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 13 inclusion and 10 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 16 May 2017. 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?
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?
total dosis of rFSH (IU) (time frame: donors will be followed until the end of stimulation period, an expected average of 15 days). 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 NCT02490150, 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 16 May 2017.