Aneuploidies and Different Stimulation Protocols

NCT00802295 | Completed

• 1 other identifier: VLC-JR-0204-307-11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Aneuploidy

Keywords

Ovarian; hyperstimulation; Embryo; Aneuploidy; Ovarian hyperstimulation and Embryo Aneuploidy Rates

Outcome Measures

Primary Outcomes (1)

• Aneuploidy rate with two different stimulation protocols.

  three months

Secondary Outcomes (1)

• Normal blastocyst rate

  three months

Study Arms (2)

standard dosis protocol

ACTIVE COMPARATOR

Administration of standard dosis of gonadotrophins for ovarian stimulation.

Drug: Gonadotrophins

2

EXPERIMENTAL

Administration of low dosis of Gonadotrophins for ovarian stimulation

Drug: Low dosis Gonadotrophin

Interventions

Gonadotrophins DRUG

Administration of standard ovarian stimulation protocol

standard dosis protocol

Low dosis Gonadotrophin DRUG

2

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• donors with 2 previous miscarriages
• PCO
• Severe Male Factor

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead

Study Sites (1)

Instituto Valenciano de Infertilidad

Valencia, 46015, Spain

Location

Related Publications (1)

• 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.

  PMID: 20627979 DERIVED

MeSH Terms

Conditions

Aneuploidy

Interventions

Gonadotropins

Condition Hierarchy (Ancestors)

Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jose Remohi, MD PhD

  IVI Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: December 4, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 18, 2009

Record last verified: 2009-09

Locations

ES (1)