Progevera 10 mg® Versus Orgalutran® in Ovarian Stimulatio... | NCT02796105

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

NCT02796105

Sponsor

Fundació Privada Eugin

Status

Completed

Last Update Posted

Sep 13, 2017Actual

Enrollment

232Actual

Phase

Phase 4

Conditions

Infertility

Interventions

Progevera
Orgalutran

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 10, 2017Actual

First Submitted Date

Jun 7, 2016

First Submission Date that Met QC Criteria

Jun 9, 2016

First Posted Date

Jun 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2017

Last Update Posted Date

Sep 13, 2017Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

232Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Progevera	Experimental	Progevera 10 mg	Drug: Progevera
Orgalutran	Active Comparator	Orgalutran 0.25 mg	Drug: Orgalutran

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Progevera	Drug		Progevera
Orgalutran

Measure	Description	Time Frame
donor ovarian response		1 month

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rebeca Begueria, Dr	Clinica Eugin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinica Eugin		Barcelona			Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30927417	Derived	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.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases