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

Ovarian Stimulation Clinical Trial

— TAIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939403
• Other study ID #: IB-0319-002
• Status: Completed
• Phase: Phase 4
• Start date: November 18, 2019
• Est. completion date: May 8, 2021

Study information

• Verified date: May 2021
• Source: Instituto Bernabeu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 8, 2021
• Est. primary completion date: May 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 32 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Stimulation

Intervention

Drug:
• Time of administration of Corifollitropin Alfa
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.

Locations

Country	Name	City	State
Spain	Instituto Bernabeu	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Bernabeu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes	Number of oocytes after stimulation	At the end of stimulation