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Enrolling by Invitation

NCT Number: NCT07349966

Effects of Trophectoderm (TE) Biopsy on the Health and Development of Children Born After Preimplantation Genetic Testing (PGT) Cycles.

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.

Enrolling by Invitation

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Key information

Conditions

Preimplantation Genetic Testing (PGT) Assisted Reproduction Technologies Frozen Embryo Transfer Cycle Postnatal Health

Age range

Up to 60 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Irccs San Raffaele Hospital

Milan, Milano, 20132, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Other

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).

Primary outcomes

  1. Impact of Blastocyst Biopsy on Postnatal Growth at One Year

    Time frame: 12 months of life of children

    Questionnaire

Secondary outcomes

  1. Long-Term Growth After Blastocyst Biopsy

    Time frame: At birth of children and at 60 months of age

    Questionnaire

Other outcomes

  1. Exploratory Objectives: Health and development of children at the first and fifth years of life.

    Time frame: At 12 and at 60 months of age

    Questionnaire

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

A Prospective Observational Study of the Impact of Blastocyst Biopsy on Postnatal Growth in Children Born After Preimplantation Genetic Testing

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 20, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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