Impact of Three Different Gonadotrophin Regimes on Egg Donation Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00829075
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : January 26, 2009
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Condition or disease Intervention/treatment Phase
Ovarian Stimulation Drug: r-FSH Drug: HP-hMG Drug: r-FSH plus HP-hMG Phase 4

Study Type : Interventional  (Clinical Trial)
Official Title: A Prospective, Randomized, Controlled Trial Comparing Three Different Gonadotrophin Regimens in Oocyte Donors: Ovarian Response and IVF Outcome
Study Start Date : January 2005
Actual Study Completion Date : December 2006

Arm Intervention/treatment
Experimental: I
Drug: r-FSH
Experimental: II
Drug: HP-hMG
Experimental: III
Drug: r-FSH plus HP-hMG

Primary Outcome Measures :
  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. [ Time Frame: one year ]

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00829075

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

Responsible Party: Dr. Marco Melo, IVI Valencia Identifier: NCT00829075     History of Changes
Other Study ID Numbers: VLC-MM-0501-37
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: January 26, 2009
Last Verified: January 2009