Aneuploidies and Different Stimulation Protocols

Aneuploidy Clinical Trial

Official title:

Influence of Ovarian Stimulation and Embryo Aneuploidy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802295
• Other study ID #: VLC-JR-0204-307-11
• Status: Completed
• Phase: N/A
• First received: December 3, 2008
• Last updated: September 17, 2009
• Start date: December 2008
• Est. completion date: April 2009

Study information

• Verified date: September 2009
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 29 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aneuploidy

Intervention

Drug:
• Gonadotrophins
Administration of standard ovarian stimulation protocol
• Low dosis Gonadotrophin

Locations

Country	Name	City	State
Spain	Instituto Valenciano de Infertilidad	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aneuploidy rate with two different stimulation protocols.		three months	No
Secondary	Normal blastocyst rate		three months	No