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Enrolling by invitationNCT07349966Updated Jun 23, 2026

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

An observational study in Preimplantation Genetic Testing (PGT), Frozen Embryo Transfer Cycle and Assisted Reproduction Technologies, sponsored by IRCCS San Raffaele. Enrolling by invitation at 1 site in Italy. Open to participants aged Up to 60 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by IRCCS San Raffaele · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
330
Ages
Up to 60 Months
Sex
All
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Study 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.

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Conditions studied

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

Keywords

  • ART
  • PGT
  • FET
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In context

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 60 Months
Sexes eligible
All
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.

Eligibility criteria

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
330 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Cases

    110 children born as single live births after their mothers underwent a PGT cycle followed by frozen embryo transfer (FET).

    Other: Questionnaire

  • Controls

    220 children born as single live births after their mothers underwent only FET.

    Other: Questionnaire

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).

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What researchers measure

Primary outcomes

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

    Questionnaire

    Time frame: 12 months of life of children

Secondary outcomes

  1. Long-Term Growth After Blastocyst Biopsy

    Questionnaire

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

Other outcomes

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

    Questionnaire

    Time frame: At 12 and at 60 months of age

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Study locations

1 site
  • Irccs San Raffaele Hospital
    Milan, Milano 20132, Italy
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References and documents

Publications

  • Alteri A, Campo G, Pagliardini L, Privitera L, Cavoretto PI, Candiani M, Papaleo E, Vigano P. The effect of vitrified-warmed blastocyst transfer on postnatal growth: a 1-year follow-up questionnaire study. Reprod Biomed Online. 2022 May;44(5):907-914. doi: 10.1016/j.rbmo.2021.12.018. Epub 2022 Jan 16. PubMed 35219589 ↗
  • Alteri A, Cermisoni GC, Pozzoni M, Gaeta G, Cavoretto PI, Vigano P. Obstetric, neonatal, and child health outcomes following embryo biopsy for preimplantation genetic testing. Hum Reprod Update. 2023 May 2;29(3):291-306. doi: 10.1093/humupd/dmad001. PubMed 36655536 ↗
  • von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ. 2007 Oct 20;335(7624):806-8. doi: 10.1136/bmj.39335.541782.AD. PubMed 17947786 ↗
  • Hou W, Shi G, Ma Y, Liu Y, Lu M, Fan X, Sun Y. Impact of preimplantation genetic testing on obstetric and neonatal outcomes: a systematic review and meta-analysis. Fertil Steril. 2021 Oct;116(4):990-1000. doi: 10.1016/j.fertnstert.2021.06.040. Epub 2021 Aug 7. PubMed 34373103 ↗
  • Magnus P, Birke C, Vejrup K, Haugan A, Alsaker E, Daltveit AK, Handal M, Haugen M, Hoiseth G, Knudsen GP, Paltiel L, Schreuder P, Tambs K, Vold L, Stoltenberg C. Cohort Profile Update: The Norwegian Mother and Child Cohort Study (MoBa). Int J Epidemiol. 2016 Apr;45(2):382-8. doi: 10.1093/ije/dyw029. Epub 2016 Apr 10. PubMed 27063603 ↗
  • Ong YY, Sadananthan SA, Aris IM, Tint MT, Yuan WL, Huang JY, Chan YH, Ng S, Loy SL, Velan SS, Fortier MV, Godfrey KM, Shek L, Tan KH, Gluckman PD, Yap F, Choo JTL, Ling LH, Tan K, Chen L, Karnani N, Chong YS, Eriksson JG, Wlodek ME, Chan SY, Lee YS, Michael N. Mismatch between poor fetal growth and rapid postnatal weight gain in the first 2 years of life is associated with higher blood pressure and insulin resistance without increased adiposity in childhood: the GUSTO cohort study. Int J Epidemiol. 2020 Oct 1;49(5):1591-1603. doi: 10.1093/ije/dyaa143. PubMed 32851407 ↗
  • Waynforth D. Effects of Conception Using Assisted Reproductive Technologies on Infant Health and Development: An Evolutionary Perspective and Analysis Using UK Millennium Cohort Data. Yale J Biol Med. 2018 Sep 21;91(3):225-235. eCollection 2018 Sep. PubMed 30258309 ↗
  • Zheng W, Yang C, Yang S, Sun S, Mu M, Rao M, Zu R, Yan J, Ren B, Yang R, Guan Y. Obstetric and neonatal outcomes of pregnancies resulting from preimplantation genetic testing: a systematic review and meta-analysis. Hum Reprod Update. 2021 Oct 18;27(6):989-1012. doi: 10.1093/humupd/dmab027. PubMed 34473268 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07349966
Lead sponsor
IRCCS San Raffaele
Responsible party
Enrico Papaleo (Principal Investigator, IRCCS San Raffaele) — Principal investigator
First posted
Jan 20, 2026
Start date
Mar 19, 2026
Primary completion
Oct 27, 2028 (estimated)
Completion
Oct 27, 2028 (estimated)
Last update
Jun 23, 2026

Study contacts

ENRICO PAPALEO, MD
principal investigator · IRCCS San Raffaele

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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