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

• Sponsor: Fundació Privada Eugin (Other)
• Overall Status: Completed
• CT.gov ID: NCT02796105
• Collaborator: (none)
• Enrollment: 232
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.3
• Patients Per Site Per Month: 17.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Progevera; Drug: Orgalutran	Phase 4

Study Design

• Study Type: Interventional
• 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: Jun 1, 2016
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 10, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. donor ovarian response [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Clinica Eugin	Barcelona		Spain

Sponsors and Collaborators

• Fundació Privada Eugin

Investigators

• Principal Investigator: Rebeca Begueria, Dr, Clinica Eugin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fundació Privada Eugin
• ClinicalTrials.gov Identifier: NCT02796105
• Other Study ID Numbers: BRAKE
• First Posted: Jun 10, 2016
• Last Update Posted: Sep 13, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Infertility; Ganirelix

Study Results

No Results Posted as of Sep 13, 2017