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Progevera 10 mg® Versus Orgalutran® in Ovarian Stimulation Cycles of Oocyte Donors

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02796105
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Fundació Privada Eugin

Tracking Information
First Submitted Date  ICMJE June 7, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date September 13, 2017
Actual Study Start Date  ICMJE June 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
donor ovarian response [ Time Frame: 1 month ]
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 Progevera 10 mg® Versus Orgalutran® in Ovarian Stimulation Cycles of Oocyte Donors
Official Title  ICMJE Evaluation of Efficacy and Safety of Medroxiprogesterone Acetate (Progevera 10 mg®) Versus GnRh Antagonist (Orgalutran®) in Ovarian Stimulation Cycles of Oocyte Donors
Brief Summary Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors
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: Other
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: Progevera
  • Drug: Orgalutran
Study Arms  ICMJE
  • Experimental: Progevera
    Progevera 10 mg
    Intervention: Drug: Progevera
  • Active Comparator: Orgalutran
    Orgalutran 0.25 mg
    Intervention: Drug: Orgalutran
Publications * Beguería R, García D, Vassena R, Rodríguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.

*   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: September 12, 2017)
232
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2016)
200
Actual Study Completion Date  ICMJE July 10, 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Oocyte donors included in the oocyte donation program of Clinica EUGIN.
  • 1st oocyte donation cycle at Clínica EUGIN.

Exclusion Criteria:

  • Polycistic Ovarian syndrome (PCOs).
  • Estradiol levels on day 2 of menstrual cycle >70 pg/ml.
  • Hormone treatments up to 3 months before the oocyte donation cycle.
  • Medical contraindication to the treatments used in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT02796105
Other Study ID Numbers  ICMJE BRAKE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundació Privada Eugin
Study Sponsor  ICMJE Fundació Privada Eugin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rebeca Begueria, Dr Clinica Eugin
PRS Account Fundació Privada Eugin
Verification Date September 2017

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