Impact of Three Different Gonadotrophin Regimes on Egg Donation Program

This study has been completed.
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA Identifier:
First received: January 23, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
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, IVI VALENCIA:

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
Drug: r-FSH
Experimental: II
Drug: HP-hMG
Experimental: III
Drug: r-FSH plus HP-hMG


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

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
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Please refer to this study by its identifier: NCT00829075

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

No publications provided

Responsible Party: Dr. Marco Melo, IVI Valencia 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 processed this record on November 25, 2015