Ovarian StimulationPhase 4TAILNCT03939403
Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor
A Phase 4 study testing Time of administration of Corifollitropin Alfa in people with Ovarian Stimulation, run by Instituto Bernabeu at 1 site in Spain.
Trial summary
This study aims to study the efficiency of using a single injection of Corifollitropin alfa for ovarian stimulation by initiating administration late and without further administration of follicle-stimulating hormone after the 7th day of stimulation compared to conventional ovarian stimulation using Corifollitropin… Read more about this study
- Who is it for?
- Ages 18 to 32 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Stimulation
- What is being tested?
- Time of administration of Corifollitropin Alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 18 Nov 2019to 8 May 2021
- 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 32 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligible for oocyte donation program
- Age between 18 and 32 years old
- BMI >18 and <30
- Antral follicle count >12 (summing both ovaries)
- Presence of both ovaries
- Ability to participate in and comply with study protocol
- Signed informed consent
- No treatment with ovulation stimulators in the 3 months prior to the start of stimulation.
Who cannot join
- Diagnosis of endometriosis at any stage
- AFC >20
- Polycystic ovary syndrome
- Concurrent participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor. A Randomized Clinical Trial. TAIL Study
This study aims to study the efficiency of using a single injection of Corifollitropin alfa for ovarian stimulation by initiating administration late and without further administration of follicle-stimulating hormone after the 7th day of stimulation compared to conventional ovarian stimulation using Corifollitropin alfa (drug administration 5 days after cessation of hormonal contraceptive and supplementation with follicle-stimulating hormone daily administration from the 8th day of stimulation).
This a controlled randomized clinical study and 180 patients will be recruited (90 per arm) and the primary study outcome is the number of obtained oocytes.
- Conditions
- Ovarian Stimulation
- Being tested
- Time of administration of Corifollitropin Alfa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time of administration of Corifollitropin AlfaDrug
The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity.
The control grup will receive the treatment on the 5th day after the cessation of hormonal contraceptive use. The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity.
The intervention grup will receive the treatment on the 7th day after the cessation of hormonal contraceptive use.
| Study group | Role | What they receive |
|---|---|---|
| 7-days pill free interval | Experimental | Not described Receives: Drug: Time of administration of Corifollitropin Alfa |
| 5-days pill free interval | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes
Number of oocytes after stimulation
Measured: At the end of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start18 Nov 2019
- Primary completion8 May 2021
- Study completion8 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian StimulationStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Bernabeu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquín Llácer, Instituto Bernabeu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939403
- Sponsor's protocol ID
- IB-0319-002
- Acronym
- TAIL
- Status last verified
- May 2021
- First submitted
- 3 May 2019
- Last updated
- 19 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor. A Randomized Clinical Trial. TAIL Study
- ClinicalTrials.gov ID
- NCT03939403
- Acronym / sponsor ID
- TAIL / IB-0319-002
- Conditions
- Ovarian Stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Instituto BernabeuUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 8 May 2021 (actual)
- Study completion
- 8 May 2021 (actual)
- First posted
- 6 May 2019 (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 study aims to study the efficiency of using a single injection of Corifollitropin alfa for ovarian stimulation by initiating administration late and without further administration of follicle-stimulating hormone after the 7th day of stimulation compared to conventional ovarian stimulation using Corifollitropin alfa (drug administration 5 days after cessation of hormonal contraceptive and supplementation with follicle-stimulating hormone daily administration from the 8th day of stimulation).
This a controlled randomized clinical study and 180 patients will be recruited (90 per arm) and the primary study outcome is the number of obtained oocytes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7-days pill free interval | Experimental | Drug: Time of administration of Corifollitropin Alfa |
| 5-days pill free interval | No intervention | – |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Eligible for oocyte donation program
- Age between 18 and 32 years old
- BMI >18 and <30
- Antral follicle count >12 (summing both ovaries)
- Presence of both ovaries
Key exclusion criteria (4 listed)
- Diagnosis of endometriosis at any stage
- AFC >20
- Polycystic ovary syndrome
- Concurrent participation in another study
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 |
|---|---|---|
| Time of administration of Corifollitropin AlfaThe used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity. The control grup will receive the treatment on the 5th day after the cessation of hormonal contraceptive use. The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity. The intervention grup will receive the treatment on the 7th day after the cessation of hormonal contraceptive use. | Drug | 7-days pill free interval |
Primary outcome
Number of oocytes
Time frame: At the end of stimulation
Number of oocytes after stimulation
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 19 May 2021.
- Individual participant dataSharing planned: Undecided
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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 Time of administration of Corifollitropin Alfa in people with Ovarian Stimulation, run by Instituto Bernabeu 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 8 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 19 May 2021. 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?
Number of oocytes (time frame: At the end of stimulation). 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 19 May 2021.