Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03939403
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Joaquín Llácer, Instituto Bernabeu

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
Ovarian Stimulation Drug: Time of administration of Corifollitropin Alfa Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 18, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : November 1, 2020

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



Primary Outcome Measures :
  1. Number of oocytes [ Time Frame: At the end of stimulation ]
    Number of oocytes after stimulation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 32 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939403


Contacts
Layout table for location contacts
Contact: Anna Pitas +34663926079 apitas@institutobernabeu.com

Locations
Layout table for location information
Spain
Instituto Bernabeu Recruiting
Alicante, Spain, 03016
Sponsors and Collaborators
Instituto Bernabeu
Layout table for additonal information
Responsible Party: Joaquín Llácer, Principal Investigator, Instituto Bernabeu
ClinicalTrials.gov Identifier: NCT03939403    
Other Study ID Numbers: IB-0319-002
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No