NCT01571076

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Igenomix · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.).

Detailed description

The randomized controlled trial results of advanced maternal age was completed and published (Rubio et al., Fertility\&Sterility 2017). The randomized controlled trial results of the male factor indication was terminated with anticipation due to the change of the technology that prevented recruitment of patients using the old technology (that one used in the study).

Conditions

• Embryo Aneuploidies
• Implantation Rates
• Infertility

Interventions

Type	Name	Description
GENETIC	PGS	Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.
GENETIC	PGS	Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.
OTHER	Prolonged culture	The embryos will be in prolonged culture and on going embryos transferred on Day 5 .
OTHER	Prolonged culture	Prolonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts.

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-09-01
• Completion: 2015-02-01
• First posted: 2012-04-04
• Last updated: 2021-01-19

Locations

1 site across 1 country: Spain