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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

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

Clinicaltrials.gov identifier NCT03939403

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted June 23, 2020

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:Ovarian Stimulation
  • Intervention/Treatment: Drug: Time of administration of Corifollitropin Alfa
  • Phase: Phase 4
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: August 2020
  • Estimated Study Completion Date: November 2020
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.
Outcome Measures
  • Primary Outcome Measures: 1. Number of oocytes [ Time Frame: At the end of stimulation ]
    Number of oocytes after stimulation
Eligibility Criteria
  • Ages Eligible for Study: 18 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 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
Contacts

Contact: Anna Pitas +34663926079 apitas@institutobernabeu.com

Locations

Spain
Instituto Bernabeu
Alicante

Sponsors and Collaborators

Instituto Bernabeu

More Information
  • Responsible Party: Instituto Bernabeu
  • ClinicalTrials.gov Identifier: NCT03939403 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No