NCT00829075

Brief Summary

Exploratory study assessing the effect of three gonadotrophin protocols on Controlled Ovarian Stimulation (COS) parameters and IVF outcome in oocyte donors undergoing GnRH analogue (long protocol). 1,028 donors were randomized in three groups: Group I (n= 346) only r-FSH, Group II (n= 333) only HP-hMG and Group III (n= 349) r-FSH plus HP-hMG. IVF outcome of 1,059 oocyte recipients was compared.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2005

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

January 1, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
Last Updated

January 26, 2009

Status Verified

January 1, 2009

First QC Date

January 23, 2009

Last Update Submit

January 23, 2009

Conditions

Ovarian Stimulation

Outcome Measures

Primary Outcomes (1)

  • The aim of this study was to verify whether different gonadotrophin regimes could affect controlled ovarian stimulation (COS) parameters and IVF outcome in an egg donation program.

    one year

Study Arms (3)

I

EXPERIMENTAL

only r-FSH TREATMENT

Drug: r-FSH

II

EXPERIMENTAL

only HP-hMG TREATMENT

Drug: HP-hMG

III

EXPERIMENTAL

r-FSH plus HP-hMG TREATMENT

Drug: r-FSH plus HP-hMG

Interventions

r-FSHDRUG
I
HP-hMGDRUG
II
r-FSH plus HP-hMGDRUG
III

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy women 18-34 years of age
  • regular menstrual cycles
  • no family history of hereditary or chromosomal diseases
  • normal karyotype
  • BMI 18-29 Kg/m2
  • negative screening for sexually transmitted diseases

You may not qualify if:

  • women with PCOS were not included in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Valencia

Valencia, 46015, Spain

Location

Study Officials

  • Marco Melo, MDPhD

    IVI Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2009

First Posted

January 26, 2009

Study Start

January 1, 2005

Study Completion

December 1, 2006

Last Updated

January 26, 2009

Record last verified: 2009-01

Locations

ES(1)