Aneuploidies and Different Stimulation Protocols
Primary Purpose
Aneuploidy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Gonadotrophins
Low dosis Gonadotrophin
Sponsored by
About this trial
This is an interventional prevention trial for Aneuploidy focused on measuring Ovarian, hyperstimulation, Embryo, Aneuploidy, Ovarian hyperstimulation and Embryo Aneuploidy Rates
Eligibility Criteria
Inclusion Criteria:
- Healthy women between 18 - 29
- with previous cycle with standard dosis of Gonadotrophin and high response to the treatment (> 20 oocytes)
- No symptom of OHSS
Exclusion Criteria:
- donors with 2 previous miscarriages
- PCO
- Severe Male Factor
Sites / Locations
- Instituto Valenciano de Infertilidad
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard dosis protocol
2
Arm Description
Administration of standard dosis of gonadotrophins for ovarian stimulation.
Administration of low dosis of Gonadotrophins for ovarian stimulation
Outcomes
Primary Outcome Measures
Aneuploidy rate with two different stimulation protocols.
Secondary Outcome Measures
Normal blastocyst rate
Full Information
NCT ID
NCT00802295
First Posted
December 3, 2008
Last Updated
September 17, 2009
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
1. Study Identification
Unique Protocol Identification Number
NCT00802295
Brief Title
Aneuploidies and Different Stimulation Protocols
Official Title
Influence of Ovarian Stimulation and Embryo Aneuploidy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our working hypothesis is that patients undergoing "in vitro" fertilization (IVF) with higher response to ovarian stimulation protocols recover a higher number of oocytes and, this elevated response could be translated into increased incidence of chromosomally abnormal embryos. Our objective is to develop a prospective study on healthy young donors, with a previous cycle with high ovarian response (>20 oocytes and/or E2 levels the day of the hCG injection >3000 pg/mL), but without developing mild or severe hyperstimulation syndrome. After signing a proper written consent, these donors would agree to undergo two subsequent stimulation cycles following two different protocols. In one cycle the stimulation pattern would be similar to the previous one, with elevated response and, in another cycle the amount of gonadotropins would be cut down in order to obtain lower ovarian response. Oocytes obtained in each cycle would be donated to anonymous recipients and after fertilization, embryo quality and chromosomal status of the resulting embryos would be evaluated. Preimplantation genetic diagnosis (PGD) will be performed on day-3 embryos and chromosomes 13, 15, 16, 17, 18, 21, 22, X and Y would be analyzed by fluorescence "in situ" hybridization (FISH).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneuploidy
Keywords
Ovarian, hyperstimulation, Embryo, Aneuploidy, Ovarian hyperstimulation and Embryo Aneuploidy Rates
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard dosis protocol
Arm Type
Active Comparator
Arm Description
Administration of standard dosis of gonadotrophins for ovarian stimulation.
Arm Title
2
Arm Type
Experimental
Arm Description
Administration of low dosis of Gonadotrophins for ovarian stimulation
Intervention Type
Drug
Intervention Name(s)
Gonadotrophins
Intervention Description
Administration of standard ovarian stimulation protocol
Intervention Type
Drug
Intervention Name(s)
Low dosis Gonadotrophin
Primary Outcome Measure Information:
Title
Aneuploidy rate with two different stimulation protocols.
Time Frame
three months
Secondary Outcome Measure Information:
Title
Normal blastocyst rate
Time Frame
three months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy women between 18 - 29
with previous cycle with standard dosis of Gonadotrophin and high response to the treatment (> 20 oocytes)
No symptom of OHSS
Exclusion Criteria:
donors with 2 previous miscarriages
PCO
Severe Male Factor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Remohi, MD PhD
Organizational Affiliation
IVI Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Valenciano de Infertilidad
City
Valencia
ZIP/Postal Code
46015
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
20627979
Citation
Rubio C, Mercader A, Alama P, Lizan C, Rodrigo L, Labarta E, Melo M, Pellicer A, Remohi J. Prospective cohort study in high responder oocyte donors using two hormonal stimulation protocols: impact on embryo aneuploidy and development. Hum Reprod. 2010 Sep;25(9):2290-7. doi: 10.1093/humrep/deq174. Epub 2010 Jul 13.
Results Reference
derived
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Aneuploidies and Different Stimulation Protocols
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