Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524648
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multicenter Observational Pilot Study to Evaluate the Combination of niPGT-A and Morphokinetics for the Non-invasive Assessment of Embryo Development
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANDORA
Brief Summary:
Choosing the best embryo is one of the major challenges for achieving success in in vitro fertilization IVF Traditionally embryo evaluation has been based on morphological quality how the embryo looks like and chromosomal status as diagnosed by a genetic testing However recently new techniques that do not require manipulation of the embryo have been developed and have shown promising results
The goal of this observational study is by combining two non-invasive techniques to find out some parameters during embryo development which may be related with the embryos chromosomic status For that infertile women planning to undergo an IVFICSI treatment with a recommended niPGT-A non-invasive Preimplantation Genetic Testing for Aneuploidies will be invited to join the study The main question it aims to answer is
Can morphokinetics parameters correlate with embryo chromosomal status
Participants will follow their previously programmed IVFICSI treatment and no additional visitsinterventions will be required by their participation in the study The obtained embryos will be cultured in a time-lapse system instead of in a conventional incubator and niPGT-A will be performed Following the standard practice a deferred single embryo transfer SET will be performed according to the niPGT-A results After the transfer patients will be followed-up as usual
The goal of this observational study is by combining two non-invasive techniques to find out some parameters during embryo development which may be related with the embryos chromosomic status For that infertile women planning to undergo an IVFICSI treatment with a recommended niPGT-A non-invasive Preimplantation Genetic Testing for Aneuploidies will be invited to join the study The main question it aims to answer is
Can morphokinetics parameters correlate with embryo chromosomal status
Participants will follow their previously programmed IVFICSI treatment and no additional visitsinterventions will be required by their participation in the study The obtained embryos will be cultured in a time-lapse system instead of in a conventional incubator and niPGT-A will be performed Following the standard practice a deferred single embryo transfer SET will be performed according to the niPGT-A results After the transfer patients will be followed-up as usual
Detailed Description:
Embryo selection represents one of the major challenges for achieving success in in vitro fertilization IVF cycles Traditionally embryo evaluation has been based on morphological quality and chromosomal status as diagnosed by a genetic testing However recently new non-invasive techniques that do not require additional manipulation of the embryo have been developed and have shown promising results One such technique is the time-lapse TL system imaging which considers the embryos development in relation to its rate of division and evolution morphokinetics Several algorithms have been developed to aid in the selection of embryos with the highest potential for implantation by collecting data on morphokinetic events during in vitro preimplantation development Another non-invasive method is the analysis of the cell-free desoxyribonucleic acid cfDNA in the culture medium considered as a non-invasive preimplantation genetic testing for aneuploidies niPGT-A Despite both techniques have shown promising results each one has its limitations and further research is necessary to identify synergies between them with the aim of finding a more powerful approach for embryo viability evaluation
The combination of TL and niPGT-A might have the potential to improve the embryo evaluation and thus to improve the reproductive outcome rates in IVF treatments Therefore the aim of the present pilot study is to identify morphokinetic parameters during embryo development in a time-lapse system which may correlate with niPGT-A results
Once the study is approved by the competent Research Ethics Committee of each center the recruitment and selection of patients will follow Every potential participant will be asked to sign the study informed consent To comply with the study design and the proposed hypothesis an estimated total number of 200 patients will be recruited
This is a multicenter international competitive observational prospective cohort study in which infertile women scheduled for an IVFICSI treatment with medical recommendation of niPGT-A will have their embryos cultured in a time-lapse system instead of in a standard incubator On day 67 of embryo development the embryos culture medium will be collected and analyzed by niPGT-A A subsequent embryo transfer will be performed following the niPGT-A report recommendation and participants will be followed up as routine by their gynecologist If a pregnancy is achieved participants will be followed up until the 12th gestational week and if possible until the delivery If pregnancy is not achieved patients can perform as many SETCOS as they need during the study recruitment period
Data exported from the medical records and source documents will be duly codified to protect the clinical and personal information of patients in accordance with the current legislation on data protection This information will be exported to an internal database An interim data analysis will be carried out once the 50 of the niPGT-A cycles 100 cycles is reached It will help us to assess the enrollment rate protocol compliance and an early evaluation of the study objectives
Patients participation will comprise an estimated total time of up to 11 months 1 month for the COS cycle 1 month for the ET cycle 9 months for the follow-up period 12th gestational week and 40th gestational week when applicable
The combination of TL and niPGT-A might have the potential to improve the embryo evaluation and thus to improve the reproductive outcome rates in IVF treatments Therefore the aim of the present pilot study is to identify morphokinetic parameters during embryo development in a time-lapse system which may correlate with niPGT-A results
Once the study is approved by the competent Research Ethics Committee of each center the recruitment and selection of patients will follow Every potential participant will be asked to sign the study informed consent To comply with the study design and the proposed hypothesis an estimated total number of 200 patients will be recruited
This is a multicenter international competitive observational prospective cohort study in which infertile women scheduled for an IVFICSI treatment with medical recommendation of niPGT-A will have their embryos cultured in a time-lapse system instead of in a standard incubator On day 67 of embryo development the embryos culture medium will be collected and analyzed by niPGT-A A subsequent embryo transfer will be performed following the niPGT-A report recommendation and participants will be followed up as routine by their gynecologist If a pregnancy is achieved participants will be followed up until the 12th gestational week and if possible until the delivery If pregnancy is not achieved patients can perform as many SETCOS as they need during the study recruitment period
Data exported from the medical records and source documents will be duly codified to protect the clinical and personal information of patients in accordance with the current legislation on data protection This information will be exported to an internal database An interim data analysis will be carried out once the 50 of the niPGT-A cycles 100 cycles is reached It will help us to assess the enrollment rate protocol compliance and an early evaluation of the study objectives
Patients participation will comprise an estimated total time of up to 11 months 1 month for the COS cycle 1 month for the ET cycle 9 months for the follow-up period 12th gestational week and 40th gestational week when applicable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None