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Impact of Three Different Gonadotrophin Regimes on Egg Donation Program

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT00829075
First received: January 23, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Ovarian Stimulation
 Drug: r-FSH
Drug: HP-hMG
Drug: r-FSH plus HP-hMG
 Phase 4

Study Type: Interventional
Official Title: A Prospective, Randomized, Controlled Trial Comparing Three Different Gonadotrophin Regimens in Oocyte Donors: Ovarian Response and IVF Outcome

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • 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. [ Time Frame: one year ] [ Designated as safety issue: No ]

Study Start Date: January 2005
Study Completion Date: December 2006
Arms Assigned Interventions
Experimental: I
only r-FSH TREATMENT
 Drug: r-FSH
Experimental: II
only HP-hMG TREATMENT
 Drug: HP-hMG
Experimental: III
r-FSH plus HP-hMG TREATMENT
 Drug: r-FSH plus HP-hMG

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • women with PCOS were not included in this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829075

Locations
Spain
IVI Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
Investigators
Principal Investigator: Marco Melo, MDPhD IVI Valencia
  More Information

No publications provided

Responsible Party: Dr. Marco Melo, IVI Valencia
ClinicalTrials.gov Identifier: NCT00829075     History of Changes
Other Study ID Numbers: VLC-MM-0501-37
Study First Received: January 23, 2009
Last Updated: January 23, 2009
Health Authority: Spain: Ministry of Health

ClinicalTrials.gov processed this record on May 19, 2013