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

January 13, 2026 updated by: Enrico Papaleo, IRCCS San Raffaele

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Milano
      • Milan, Milano, Italy, 20132
        • IRCCS San Raffaele Hospital
        • Contact:
        • Principal Investigator:
          • ENRICO PAPALEO, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will involve a total of 330 children born as single live births after their mothers underwent assisted reproduction technology (ART) treatment. The participant population includes:

  • Cases: 110 children born as single live births after their mothers underwent a PGT cycle followed by frozen embryo transfer (FET).
  • Controls: 220 children born as single live births after their mothers underwent only FET.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
110 children born as single live births after their mothers underwent a PGT cycle followed by frozen embryo transfer (FET).
Other: Questionnaire
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).
Controls
220 children born as single live births after their mothers underwent only FET.
Other: Questionnaire
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Blastocyst Biopsy on Postnatal Growth at One Year
Time Frame: 12 months of life of children
Questionnaire
12 months of life of children

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-Term Growth After Blastocyst Biopsy
Time Frame: At birth of children and at 60 months of age
Questionnaire
At birth of children and at 60 months of age

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 12 and at 60 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: ENRICO PAPALEO, MD, IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 22, 2025

Primary Completion (Estimated)

October 27, 2028

Study Completion (Estimated)

October 27, 2028

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BABYPGT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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