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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

Study Description
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Brief Summary:
Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors

Condition or disease Intervention/treatment Phase
Infertility Drug: Progevera Drug: Orgalutran Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Efficacy and Safety of Medroxiprogesterone Acetate (Progevera 10 mg®) Versus GnRh Antagonist (Orgalutran®) in Ovarian Stimulation Cycles of Oocyte Donors
Actual Study Start Date : June 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 10, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Progevera
Progevera 10 mg
 Drug: Progevera
Active Comparator: Orgalutran
Orgalutran 0.25 mg
 Drug: Orgalutran


Outcome Measures
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Primary Outcome Measures :
  1. donor ovarian response [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02796105


Locations
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Spain
Clinica Eugin
Barcelona, Spain
Sponsors and Collaborators
Fundació Privada Eugin
Investigators
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Principal Investigator: Rebeca Begueria, Dr Clinica Eugin
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fundació Privada Eugin
ClinicalTrials.gov Identifier: NCT02796105    
Other Study ID Numbers: BRAKE
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Ganirelix
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs