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GnRH Agonist and Antagonists in an Oocyte Donation Program

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ClinicalTrials.gov Identifier: NCT00505817
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : January 12, 2009
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA

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
Effect of Two Protocols of Ovarian Stimulation on Oocyte Quality 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 Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)

Resource links provided by the National Library of Medicine

Drug Information available for: Cetrorelix
U.S. FDA Resources





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

Inclusion Criteria:

  • oocyte donors with age range: 18 - 34; BMI: 18 - 29 kg/m2;

Exclusion Criteria:

  • PCO

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): NCT00505817


Locations
Spain
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

ClinicalTrials.gov Identifier: NCT00505817     History of Changes
Other Study ID Numbers: VLC-MM-0706-307-19
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: January 12, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Leuprolide
Cetrorelix
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists