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

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Stimulation
• Intervention / Treatment: Drug: Time of administration of Corifollitropin Alfa

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03016
    • Instituto Bernabeu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 32 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 7-days pill free interval	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.
No Intervention: 5-days pill free interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of oocytes	Number of oocytes after stimulation	At the end of stimulation

Collaborators and Investigators

• Sponsor: Instituto Bernabeu

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Actual): May 8, 2021
• Study Completion (Actual): May 8, 2021

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IB-0319-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No