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

September 12, 2017 updated by: Fundació Privada Eugin

Evaluation of Efficacy and Safety of Medroxiprogesterone Acetate (Progevera 10 mg®) Versus GnRh Antagonist (Orgalutran®) in Ovarian Stimulation Cycles of Oocyte Donors

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Clinica EUGIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Progevera
Progevera 10 mg
Drug: Progevera
Active Comparator: Orgalutran
Orgalutran 0.25 mg
Drug: Orgalutran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
donor ovarian response
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Privada Eugin

Investigators

  • Principal Investigator: Rebeca Begueria, Dr, Clinica EUGIN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 10, 2017

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRAKE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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