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

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.

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Key information

Conditions

OVARIAN STIMULATION

Age range

18 year–32 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Bernabeu

Alicante, 03016, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

time of administration of Corifollitropin Alfa

Drug

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.

Primary outcomes

Number of oocytes

Time frame: At the end of stimulation

Number of oocytes after stimulation

Sponsors and collaborators

Lead sponsor

Instituto Bernabeu

Other

Registry information

Official study title

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

Acronym: TAIL

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: May 6, 2019
Registry last updated: May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed