- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00505817
GnRH Agonist and Antagonists in an Oocyte Donation Program
January 9, 2009 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Valencia, Spain, 46015
- Instituto Valenciano de Infertilidad Spain
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 34 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- oocyte donors with age range: 18 - 34; BMI: 18 - 29 kg/m2;
Exclusion Criteria:
- PCO
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marco Melo, MDPhD, Instituto Valenciano de Infertilidad
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 23, 2007
First Submitted That Met QC Criteria
July 23, 2007
First Posted (Estimate)
July 25, 2007
Study Record Updates
Last Update Posted (Estimate)
January 12, 2009
Last Update Submitted That Met QC Criteria
January 9, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VLC-MM-0706-307-19
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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