Clinical trial NCT02820415: PGS on Blastocysts From Vitrified and Fresh Oocytes
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Increase the Number of Blastocyst to Biopsy for Preimplantation Genetic Testing
Keywords: aneuploidy
next generation sequencing
oocyte vitrification
preimplantation genetic diagnosis
preimplantation genetic screening
Lead sponsor: Unità di Medicina della Riproduzione, Italy
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 28
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile women, normal ovarian reserve, with repeated implantation failure or reccurent miscarriage

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of euploidy in blastocyst from fresh and vitrified/warmed oocytes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sant'agata Li Battiati
country: Italy
facility: Sandrine Chamayou
Study officials:
References:
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.
citation: 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. doi: 10.1016/s1472-6483(10)61085-1.
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.
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.
citation: Chamayou S, Sicali M, Alecci C, Ragolia C, Liprino A, Nibali D, Storaci G, Cardea A, Guglielmino A. The accumulation of vitrified oocytes is a strategy to increase the number of euploid available blastocysts for transfer after preimplantation genetic testing. J Assist Reprod Genet. 2017 Apr;34(4):479-486. doi: 10.1007/s10815-016-0868-0. Epub 2017 Jan 9.