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

Sponsor
Instituto Bernabeu (Other)
Overall Status
Completed
CT.gov ID
NCT03939403
Collaborator
(none)
180
Enrollment
1
Location
2
Arms
17.6
Actual Duration (Months)
10.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Time of administration of Corifollitropin Alfa
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor. A Randomized Clinical Trial. TAIL Study
Actual Study Start Date :
Nov 18, 2019
Actual Primary Completion Date :
May 8, 2021
Actual Study Completion Date :
May 8, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of oocytes [At the end of stimulation]

    Number of oocytes after stimulation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 32 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto Bernabeu Alicante Spain 03016

Sponsors and Collaborators

  • Instituto Bernabeu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joaquín Llácer, Principal Investigator, Instituto Bernabeu
ClinicalTrials.gov Identifier:
NCT03939403
Other Study ID Numbers:
  • IB-0319-002
First Posted:
May 6, 2019
Last Update Posted:
May 19, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 19, 2021