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Impact of Three Different Gonadotrophin Regimes on Egg Donation Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829075
First Posted: January 26, 2009
Last Update Posted: January 26, 2009
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.
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA
  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, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT00829075


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

Responsible Party: Dr. Marco Melo, IVI Valencia
ClinicalTrials.gov Identifier: NCT00829075     History of Changes
Other Study ID Numbers: VLC-MM-0501-37
First Submitted: January 23, 2009
First Posted: January 26, 2009
Last Update Posted: January 26, 2009
Last Verified: January 2009