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

NCT ID: NCT02796105

Last Updated: 2017-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-07-10

Brief Summary

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

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Progevera

Progevera 10 mg

Group Type EXPERIMENTAL

Progevera

Intervention Type DRUG

Orgalutran

Orgalutran 0.25 mg

Group Type ACTIVE_COMPARATOR

Orgalutran

Intervention Type DRUG

Interventions

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Progevera

Intervention Type DRUG

Orgalutran

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fundació Privada Eugin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebeca Begueria, Dr

Role: PRINCIPAL_INVESTIGATOR

Clinica Eugin

Locations

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Clinica Eugin

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 30927417 (View on PubMed)

Other Identifiers

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BRAKE

Identifier Type: -

Identifier Source: org_study_id

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