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

NCT07349966 | Not Yet Recruiting

• 1 other identifier: BABYPGT
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ART; PGT; FET

Outcome Measures

Primary Outcomes (1)

• Impact of Blastocyst Biopsy on Postnatal Growth at One Year

  Questionnaire

  12 months of life of children

Secondary Outcomes (1)

• Long-Term Growth After Blastocyst Biopsy

  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.

  At 12 and at 60 months of age

Study Arms (2)

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

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).

Cases; Controls

Eligibility Criteria

• Age: Up to 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Irccs San Raffaele Hospital

Milan, Milano, 20132, Italy

Location

Related Publications (8)

• 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.

  PMID: 35219589 BACKGROUND

• 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.

  PMID: 36655536 BACKGROUND

• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.

  PMID: 25046131 BACKGROUND

• 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.

  PMID: 34373103 BACKGROUND

• 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.

  PMID: 27063603 BACKGROUND

• 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.

  PMID: 32851407 BACKGROUND

• 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.

  PMID: 30258309 BACKGROUND

• 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.

  PMID: 34473268 BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• ENRICO PAPALEO, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LUCA PAGLIARDINI, PhD

CONTACT

0226434834; pagliardini.luca@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: January 20, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): October 27, 2028
• Study Completion (Estimated): October 27, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)