An interventional study of PGS and PGS in Embryo Aneuploidies, Implantation Rates and Infertility, sponsored by Igenomix. Completed at 1 site in Spain. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-19.
Sponsored by Igenomix (part of Vitrolife) · Not applicable, Interventional, and Prevention
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.).
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).
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's enrollment of 240 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Igenomix is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
First submitted before Igenomix became part of Vitrolife.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: ADVANCED AGE and SEVERE MALE FACTOR:
Exclusion Criteria: ADVANCED AGE and SEVERE MALE FACTOR:
PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)
Other: Prolonged culture
PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)
Other: Prolonged culture
Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Advanced Age group
Genetic: PGS
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.
Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.
The embryos will be in prolonged culture and on going embryos transferred on Day 5 .
Prolonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts.
Ongoing Implantation and Pregnancy Rate
Time frame: 9 months
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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