NCT02796105

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2017

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

1.1 years

First QC Date

June 7, 2016

Last Update Submit

September 12, 2017

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • donor ovarian response

    1 month

Study Arms (2)

Progevera

EXPERIMENTAL

Progevera 10 mg

Drug: Progevera

Orgalutran

ACTIVE COMPARATOR

Orgalutran 0.25 mg

Drug: Orgalutran

Interventions

ProgeveraDRUG
Progevera
OrgalutranDRUG
Orgalutran

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Oocyte donors included in the oocyte donation program of Clinica EUGIN.
  • st oocyte donation cycle at Clínica EUGIN.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Eugin

Barcelona, Spain

Location

Related Publications (1)

  • 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.

    PMID: 30927417DERIVED

MeSH Terms

Conditions

Infertility

Interventions

ganirelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Rebeca Begueria, Dr

    Clinica Eugin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 10, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 10, 2017

Last Updated

September 13, 2017

Record last verified: 2017-09

Locations

ES(1)