Assisted Reproduction Technologies, Frozen Embryo Transfer Cycle, Postnatal Health, Preimplantation Genetic Testing (PGT)
Conditions
Keywords
ART, PGT, FET
Brief summary
This study aims to investigate the effects of trophectoderm (TE) biopsy on the health and development of children born after preimplantation genetic testing (PGT) cycles. The blastocyst biopsy is performed as part of standard clinical practice, in accordance with established protocols and current national regulations governing assisted reproduction.
Interventions
OTHERQuestionnaire
The only additional procedure involved in this study is the administration of a questionnaire to the parents, which is not part of routine clinical follow-up. The questionnaire was originally developed in the context of the Norwegian Mother and Child Cohort Study (MoBa).
Sponsors
IRCCS San Raffaele
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 60 Months
Healthy volunteers
Yes
Inclusion criteria
for Cases: * Child: Has completed the first year of life at the time of data collection. * Child: Does not have any pre-existing medical conditions that significantly affect growth (weight and height). * Mother: Able to provide informed consent for participation in the study. * Mother: Conceived between the ages of 18 and 43. * Mother: Achieved a singleton live birth with a single gestational sac. * Mother: Underwent a PGT cycle followed by FET. Inclusion Criteria for Controls: * Child: Has completed the first year of life at the time of data collection. * Child: Does not have any pre-existing medical conditions that significantly affect growth (weight and height). * Mother: Able to provide informed consent for participation in the study. * Mother: Conceived between the ages of 18 and 43. * Mother: Achieved a singleton live birth with a single gestational sac. * Mother: Underwent only FET. Participants will be excluded from this study if they meet any of the following criteria: * Mother: Unable or unwilling to sign the informed consent. * Mother: Has undergone a fresh embryo transfer. * Child: Missing birth weight or length/height data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Blastocyst Biopsy on Postnatal Growth at One Year | 12 months of life of children | Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-Term Growth After Blastocyst Biopsy | At birth of children and at 60 months of age | Questionnaire |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORENRICO PAPALEO, MD
IRCCS San Raffaele
Outcome results
None listed