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Preimplantation Genetic Screening (PGS) in Advanced Female Age and Male Severe Factor

This study is currently recruiting participants.
Verified July 2012 by Instituto Valenciano de Infertilidad, Spain
Sponsor:
Information provided by (Responsible Party):
Carlos Simon, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01571076
First received: March 29, 2012
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

Preimplantation Genetic Screening (PGS) is used for the selection of chromosomally normal embryos before the transfer in IVF treatments in many cases. There is great debate in the scientific community as to whether this is an efficient practice in patients of different prognosis.

This prospective and randomized study seeks to study the results of chromosomal diagnosis using the new Comparative Genomic hybridization (CGH) arrays technique by practicing Preimplantation Genetic Screening (PGS) in day three biopsy on one arm of the study and not on the other arm in order to compare the results. The investigators will study the ongoing pregnancy rate of each oocyte retrieval and the ongoing implantation rate with Day 5 embryos (blastocysts) in IVF/ intracytoplasmic sperm injection (ICSI) treatments of embryos from two different groups of patients: Advanced Age Female Patients (38 - 41 years of age) and Male severe factor (≥2 million spermatozoids/ml.).


Condition Intervention
Embryo Aneuploidies
Implantation Rates
Infertility
 Genetic: PGS
Other: Prolonged culture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective and Randomized Study of the Use of Comparative Genomic Hybridization (CGH) Arrays to Study Embryo Aneuploidies in Female Advanced Age and Male Factor In Vitro Fertilization (IVF) Patients.

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • Ongoing Implantation and Pregnancy Rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: June 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group B - Severe Male Factor
PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)
 Other: Prolonged culture
Prolonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts.
Experimental: Group B - Advanced Age
PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)
 Other: Prolonged culture
The embryos will be in prolonged culture and on going embryos transferred on Day 5 .
Active Comparator: Group A - Advanced Age
Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Advanced Age group
 Genetic: PGS
Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.
Active Comparator: Group A - Severe Male Factor
Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Severe Male Factor group.
 Genetic: PGS
Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: ADVANCED AGE and SEVERE MALE FACTOR:

  • Women's Age: 38- 41 years old (both included)
  • Men's Age: 18-60 years old (both included)
  • Ovulation triggered with human chorionic gonadotrophin (hCG) (Ovitrelle, Merck-Serono, Madrid)
  • Number of Oocytes metaphase II (MII): ≥ 5 (fresh, not vitrified)
  • Quality of semen: ≥ 5 millions spermatozoids/ml

Exclusion Criteria: ADVANCED AGE and SEVERE MALE FACTOR:

  • Number of Oocytes metaphase II (MII): <5 oocytes
  • Number of Oocytes obtained: >20
  • Estradiol on the day of human chorionic gonadotrophin (hCG) >3000 pgr/ml administration.
  • Progesterone on the day of hCG >1,5 pmol/l administration
  • ≥ 2 previous miscarriages:biochemical,clinical,ectopic or a combination)
  • Any un corrected alteration in a previous study.
  • Other indications of (Preimplantation Genetic Diagnosis.Screening) PGD-S, such as monogenic illnesses, translocations, repeated implantation failure, repeated miscarriages, etc.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571076

Contacts
Contact: Carmen Rubio, PhD 34963905301 carmen.rubio@ivi.es
Contact: Leslie Atkinson, MA 34963050900 leslie.atkinson@ivi.es

Locations
Spain
SPAIN: IVI Valencia, IVI Barcelona, IVI Madrid Recruiting
Valencia, Spain, 46015
Sub-Investigator: Carmen Rubio, PhD            
Sub-Investigator: Gema Castillon, MDPhD            
Sub-Investigator: Alfredo Guillen, MDPhD            
Sub-Investigator: José Bellver, MDPhD            
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
Investigators
Principal Investigator: Carlos Simon, MDPhD Director
Study Chair: Carmen Rubio, PhD Iviomics
  More Information

No publications provided

Responsible Party: Carlos Simon, Director of Clinical Research IVI Valencia, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT01571076     History of Changes
Other Study ID Numbers: 1112-C-091-CR
Study First Received: March 29, 2012
Last Updated: July 16, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
PGS
CGH
Aneuploidy
Advanced maternal age
Male factor

Additional relevant MeSH terms:
Aneuploidy
Infertility
Chromosome Aberrations
 Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013