PGS on Blastocysts From Vitrified and Fresh Oocytes

NCT ID: NCT02820415

Last Updated: 2016-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Increase the Number of Blastocyst to Biopsy for Preimplantation Genetic Testing

Study Design

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Observational Model Type

COHORT

Study Groups

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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).

chromosomal status of blastocysts from fresh and vitrified/warmed oocytes

Intervention Type OTHER

Interventions

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chromosomal status of blastocysts from fresh and vitrified/warmed oocytes

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

28 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Unità di Medicina della Riproduzione, Italy

OTHER

Sponsor Role lead

Responsible Party

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sandrine chamayou

Unità di Medicina della Riproduzione, Italy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sandrine Chamayou

Sant'Agata Li Battiati, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 21272569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16792849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23585186 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25701142 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28070710 (View on PubMed)

Other Identifiers

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Trial1

Identifier Type: -

Identifier Source: org_study_id

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