Increase the Number of Blastocyst to Biopsy for Preimplantation Genetic TestingPGSvitfreovNCT02820415
PGS on Blastocysts From Vitrified and Fresh Oocytes
An observational study of Increase the Number of Blastocyst to Biopsy for Preimplantation Genetic Testing, run by Unità di Medicina della Riproduzione, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 28 to 43 years, women only
- Conditions the study is for
- Increase the Number of Blastocyst to Biopsy for Preimplantation Genetic Testing
- What is being tested?
- chromosomal status of blastocysts from fresh and vitrified/warmed oocytes
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Dec 2015
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile women, normal ovarian reserve, with repeated implantation failure or reccurent miscarriage
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- chromosomal status of blastocysts from fresh and vitrified/warmed oocytes
- Keywords
- aneuploidy, next generation sequencing, oocyte vitrification, preimplantation genetic diagnosis, preimplantation genetic screening
- Medical subject headings
- Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chromosomal status of blastocysts from fresh and vitrified/warmed oocytesOther
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: chromosomal status of blastocysts from fresh and vitrified/warmed oocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of euploidy in blastocyst from fresh and vitrified/warmed oocytes
from fresh and vitrified/warmed oocytes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Increase the Number of Blastocyst to Biopsy for Preimplantation Genetic TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 60 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Unità di Medicina della Riproduzione, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sandrine chamayou, Unità di Medicina della Riproduzione, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820415
- Sponsor's protocol ID
- Trial1
- Acronym
- PGSvitfreov
- Status last verified
- Jun 2016
- First submitted
- 24 Jun 2016
- Last updated
- 1 Jul 2016
- Results posted
- No
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.
PubMed 21272569Chamayou 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.
PubMed 16792849Chamayou 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.
PubMed 23585186Chamayou 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.
PubMed 25701142Chamayou 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.
PubMed 28070710
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02820415
- Acronym / sponsor ID
- PGSvitfreov / Trial1
- Keywords
- aneuploidy, next generation sequencing, oocyte vitrification, preimplantation genetic diagnosis, preimplantation genetic screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Unità di Medicina della Riproduzione, ItalyUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infertile couples undergoing ICSI for PGS/PGT | – | Other: chromosomal status of blastocysts from fresh and vitrified/warmed oocytespatients 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). |
Who may qualify
- Ages
- 28 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women, normal ovarian reserve, with repeated implantation failure or reccurent miscarriage
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chromosomal status of blastocysts from fresh and vitrified/warmed oocytes | Other | infertile couples undergoing ICSI for PGS/PGT |
Primary outcome
rate of euploidy in blastocyst from fresh and vitrified/warmed oocytes
Time frame: 1 year
from fresh and vitrified/warmed oocytes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
- Background: PubMed 21272569Chamayou 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.
- Background: PubMed 16792849Chamayou 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.
- Background: PubMed 23585186Chamayou 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.
- Background: PubMed 25701142Chamayou 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.
- Derived from this study: PubMed 28070710Chamayou 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Increase the Number of Blastocyst to Biopsy for Preimplantation Genetic Testing, run by Unità di Medicina della Riproduzione, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of euploidy in blastocyst from fresh and vitrified/warmed oocytes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820415, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.