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Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor

Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor. A Randomized Clinical Trial. TAIL Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03939403
Acronym
TAIL
Enrollment
180
Registered
2019-05-06
Start date
2019-11-18
Completion date
2021-05-08
Last updated
2021-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Stimulation

Brief 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 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.

Interventions

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.

Sponsors

Instituto Bernabeu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 32 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* Diagnosis of endometriosis at any stage * AFC \>20 * Polycystic ovary syndrome * Concurrent participation in another study

Design outcomes

Primary

MeasureTime frameDescription
Number of oocytesAt the end of stimulationNumber of oocytes after stimulation

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026