PGS on Blastocysts From Vitrified and Fresh Oocytes (PGSvitfreov)

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

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.

Study Overview

• Status: Completed
• Conditions: Increase the Number of Blastocyst to Biopsy for Preimplantation Genetic Testing
• Intervention / Treatment: Other: chromosomal status of blastocysts from fresh and vitrified/warmed oocytes

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Italy
  • Sant'agata Li Battiati, Italy, 95030
    • Sandrine Chamayou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Infertile women, normal ovarian reserve, with repeated implantation failure or reccurent miscarriage

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

infertile couples undergoing ICSI for PGS/PGT; patients aged between 29.0 and 42.3 years, with basal FSH on day 3 between 2.9 and 12.0 IU/l. Undergoing 36 patients for RIF or RM. In each couple, the two partners had a normal karyotype. The patients underwent one to two cycles of ovarian stimulation to vitrify and accumulate oocytes and a last (second or third) cycle of ovarian stimulation. Ovarian stimulation was performed by the administration of recombinant FSH and LH (Gonal-F and Luveris: Merck-Serono, London, UK or Puregon, MSD, Franklin Lakes, USA) from cycle day 3 and luteal gonadotrophin-releasing hormone antagonist flexible schema (Cetrotide : Merck-Serono, London, UK).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of euploidy in blastocyst from fresh and vitrified/warmed oocytes	from fresh and vitrified/warmed oocytes	1 year

Collaborators and Investigators

• Sponsor: Unità di Medicina della Riproduzione, Italy

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Estimate): July 1, 2016
• Last Update Submitted That Met QC Criteria: June 30, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: aneuploidy; next generation sequencing; preimplantation genetic diagnosis; preimplantation genetic screening; oocyte vitrification
• Other Study ID Numbers: Trial1