GnRH Agonist and Antagonists in an Oocyte Donation Program

Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA (Other)
Overall Status
Completed
CT.gov ID
NCT00505817
Collaborator
(none)
1

Study Details

Study Description

Brief Summary

The primary purpose of this study is to evaluate the effect of the two different protocols (long protocol vs antagonist protocol) on oocyte / embryo quality.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cetrorelix and Leuprolide
Phase 4

Detailed Description

The cycles with antagonists of the GnRHa present a series of advantages with respect the GnRHa in an oocyte donation program: treatment cycles are simpler and shorter, a lower amount of dose of gonadotrophins is needed for stimulation, and most important, a decreased rate of ovarian hyperstimulation syndrome is observed. Nevertheless, several clinical trials relate their use to a greater rate of abortion and worse oocyte/ embryo quality. In order to discriminate the endometrial factor from the quality of oocyte cohort, the best strategy is the oocyte donation model. In the present study, for the first time, the effect of different protocols (long versus antagonist protocol) will be studied in the same donor, acting as its own control, undergoing COH. We will compare the COH´s parameters and IVF outcome obtained in the same donor submitted to, firstly, GnRH antagonist protocol (Cetrorelix- n= 45) versus another consecutive cycle with long protocol (Ac. Leuprolide- n= 45).

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 34 Years
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:
    • oocyte donors with age range: 18 - 34; BMI: 18 - 29 kg/m2;
    Exclusion Criteria:
    • PCO

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto Valenciano de Infertilidad Spain Valencia Spain 46015

    Sponsors and Collaborators

    • Instituto Valenciano de Infertilidad, IVI VALENCIA

    Investigators

    • Principal Investigator: Marco Melo, MDPhD, Instituto Valenciano de Infertilidad

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00505817
    Other Study ID Numbers:
    • VLC-MM-0706-307-19
    First Posted:
    Jul 25, 2007
    Last Update Posted:
    Jan 12, 2009
    Last Verified:
    Jan 1, 2009
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 12, 2009