PGS on Blastocysts From Vitrified and Fresh Oocytes

Increase the Number of Blastocyst to Biopsy for Preimplantation Genetic Testing Clinical Trial

— PGSvitfreov  

Official title:

Oocyte Accumulation by Vitrification is a Valid Strategy to Increase the Number of Euploid Available Embryos for Biopsy and Transfer After Preimplantation Genetic Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820415
• Other study ID #: Trial1
• Status: Completed
• Phase: N/A
• First received: June 24, 2016
• Last updated: June 30, 2016
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: Unità di Medicina della Riproduzione, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Oocyte accumulation by vitrification is a valid strategy to increase the number of available embryos for biopsy and the number of viable euploid embryos to transfer after preimplantation genetic testing.

Description:

In the present study, the investigators considered the hypothesis to accumulate vitrified oocytes with a view to increasing the number of oocytes for micro-injection and consequently the number of blastocyst to diagnose for patients with normal ovarian reserve and candidate for PGT. The partecipants were proposed to undergo several cycles of ovarian stimulation. In the first cycles, mature (metaphase II) oocytes were vitrified and consequently accumulated. In the last cycle, the freshly produced mature oocytes and the previously accumulated ones were micro-injected together with the same partner's semen sample. PGT was performed on blastocysts produced from the two sources of oocytes. The comprehensive chromosomal analysis of biopsied trophectoderm cells was performed using NGS technology. The number of available euploid blastocyst and the proportion of euploid/aneuploidy embryos from fresh and vitrified/warmed oocytes were compared. In conclusion the investigators evaluated the efficacy of oocyte accumulation by vitrification in increasing the number of available embryos for biopsy and the number of viable euploid embryos to transfer after PGT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 28 Years to 43 Years

Eligibility

Inclusion Criteria:

• infertile women

• normal ovarian reserve

• with repeated implantation failure or reccurent miscarriage

• undergoing ICSI and asking to know the state of health of the embryos prior to embryo transfer

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Increase the Number of Blastocyst to Biopsy for Preimplantation Genetic Testing

Intervention

Other:
• chromosomal status of blastocysts from fresh and vitrified/warmed oocytes

Locations

Country	Name	City	State
Italy	Sandrine Chamayou	Sant'agata Li Battiati

Sponsors (1)

Lead Sponsor	Collaborator
Unità di Medicina della Riproduzione, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Chamayou S, Alecci C, Ragolia C, Storaci G, Maglia E, Russo E, Guglielmino A. Comparison of in-vitro outcomes from cryopreserved oocytes and sibling fresh oocytes. Reprod Biomed Online. 2006 Jun;12(6):730-6. — View Citation

Chamayou S, Bonaventura G, Alecci C, Tibullo D, Di Raimondo F, Guglielmino A, Barcellona ML. Consequences of metaphase II oocyte cryopreservation on mRNA content. Cryobiology. 2011 Apr;62(2):130-4. doi: 10.1016/j.cryobiol.2011.01.014. Epub 2011 Jan 25. — View Citation

Chamayou S, Patrizio P, Storaci G, Tomaselli V, Alecci C, Ragolia C, Crescenzo C, Guglielmino A. The use of morphokinetic parameters to select all embryos with full capacity to implant. J Assist Reprod Genet. 2013 Jun;30(5):703-10. doi: 10.1007/s10815-013-9992-2. Epub 2013 Apr 13. — View Citation

Chamayou S, Romano S, Alecci C, Storaci G, Ragolia C, Palagiano A, Guglielmino A. Oocyte vitrification modifies nucleolar remodeling and zygote kinetics-a sibling study. J Assist Reprod Genet. 2015 Apr;32(4):581-6. doi: 10.1007/s10815-015-0446-x. Epub 2015 Feb 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of euploidy in blastocyst from fresh and vitrified/warmed oocytes	from fresh and vitrified/warmed oocytes	1 year	Yes