Back to resultsProgevera 10 mg® Versus Orgalutran® in Ovarian Stimulation Cycles of Oocyte Donors
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Progevera
Orgalutran
Sponsored by
About this trial
This is an interventional other trial for Infertility
Eligibility 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
Sites / Locations
- Clinica Eugin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Progevera
Orgalutran
Arm Description
Progevera 10 mg
Orgalutran 0.25 mg
Outcomes
Primary Outcome Measures
donor ovarian response
Secondary Outcome Measures
Full Information
NCT ID
NCT02796105
First Posted
June 7, 2016
Last Updated
September 12, 2017
Sponsor
Fundació Privada Eugin
1. Study Identification
Unique Protocol Identification Number
NCT02796105
Brief Title
Progevera 10 mg® Versus Orgalutran® in Ovarian Stimulation Cycles of Oocyte Donors
Official Title
Evaluation of Efficacy and Safety of Medroxiprogesterone Acetate (Progevera 10 mg®) Versus GnRh Antagonist (Orgalutran®) in Ovarian Stimulation Cycles of Oocyte Donors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Privada Eugin
4. Oversight
5. Study Description
Brief Summary
Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
232 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Progevera
Arm Type
Experimental
Arm Description
Progevera 10 mg
Arm Title
Orgalutran
Arm Type
Active Comparator
Arm Description
Orgalutran 0.25 mg
Intervention Type
Drug
Intervention Name(s)
Progevera
Intervention Type
Drug
Intervention Name(s)
Orgalutran
Primary Outcome Measure Information:
Title
donor ovarian response
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebeca Begueria, Dr
Organizational Affiliation
Clinica Eugin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Eugin
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
30927417
Citation
Begueria R, Garcia D, Vassena R, Rodriguez 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.
Results Reference
derived
Learn more about this trial
Progevera 10 mg® Versus Orgalutran® in Ovarian Stimulation Cycles of Oocyte Donors
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