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

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ClinicalTrials.gov Identifier: NCT03939403
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Joaquín Llácer, Instituto Bernabeu

Tracking Information
First Submitted Date  ICMJE May 3, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date May 19, 2021
Actual Study Start Date  ICMJE November 18, 2019
Actual Primary Completion Date May 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
Number of oocytes [ Time Frame: At the end of stimulation ]
Number of oocytes after stimulation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor
Official Title  ICMJE Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor. A Randomized Clinical Trial. TAIL Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Stimulation
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Experimental: 7-days pill free interval
    Intervention: Drug: Time of administration of Corifollitropin Alfa
  • No Intervention: 5-days pill free interval
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2019)
180
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 8, 2021
Actual Primary Completion Date May 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 32 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03939403
Other Study ID Numbers  ICMJE IB-0319-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Joaquín Llácer, Instituto Bernabeu
Study Sponsor  ICMJE Instituto Bernabeu
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Instituto Bernabeu
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP