Preimplantation Genetic Testing (PGT)NCT07349966

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

An observational study of Preimplantation Genetic Testing (PGT) and Frozen Embryo Transfer Cycle, run by IRCCS San Raffaele at 1 site in Italy.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages Up to 60 monthsHealthy volunteers can take part
Conditions the study is for: Preimplantation Genetic Testing (PGT), Frozen Embryo Transfer Cycle, Assisted Reproduction Technologies
What is being tested?: Questionnaire
How many people: 330 participants
Where: 1 siteItaly
Study dates: 19 Mar 2026to 27 Oct 2028
How long will I take part?: 1 Day
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 60 months
All sexes
Healthy volunteers accepted
Child

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.

Who may be able to join

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.

Show all 16Show fewer

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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site

Irccs San Raffaele Hospital
Milan, Milano, 20132

Other trials in Italy

About this study

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

Conditions: Preimplantation Genetic Testing (PGT), Frozen Embryo Transfer Cycle, Assisted Reproduction Technologies, Postnatal Health
Being tested: Questionnaire
Keywords: ART, PGT, FET

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QuestionnaireOther
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).

Study groups in NCT07349966
Study group	Role	What they receive
Cases		110 children born as single live births after their mothers underwent a PGT cycle followed by frozen embryo transfer (FET). Receives: Other: Questionnaire
Controls		220 children born as single live births after their mothers underwent only FET. Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

Impact of Blastocyst Biopsy on Postnatal Growth at One Year
Questionnaire
Measured: 12 months of life of children

Secondary outcomes (1)

Long-Term Growth After Blastocyst Biopsy
Questionnaire
Measured: At birth of children and at 60 months of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 202627 Oct 2028

First posted20 Jan 2026
Study start19 Mar 2026
Primary completion27 Oct 2028 (estimated)
Study completion27 Oct 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Preimplantation Genetic Testing (PGT)Studies of the same condition, open and under way.
More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 330 participants (estimated)
Target duration: 1 Day

IDs, dates and publications

ClinicalTrials.gov ID: NCT07349966
Sponsor's protocol ID: BABYPGT
Status last verified: Jun 2026
First submitted: 18 Nov 2025
Last updated: 23 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingObservational study
Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Couples With Non-obstructive Azoospermia (NOA)
Non-obstructive Azoospermia, Male Infertility
Not yet recruitingObservational study
Prospective International Multi-center Clinical Trial of PGT-A Upgrade
Infertility Assisted Reproductive Technology
Not yet recruitingPhase 3
Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT-A
Preimplantation Genetic Testing, Progestin-primed Ovarian Stimulation
Enrolling by invitationObservational study
Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing
Infertility, Female, Infertility, Male
Active, not recruiting
To Investigate if the Harvester® Improves Sperm Motility and Blastocyst Utilization (the Percent of Fertilized Eggs That Develop to the Point That They Are Able to be Transferred) in IVF Cycles.
Infertility, Male Infertility

All Preimplantation Genetic Testing (PGT) trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Observational Study of the Impact of Blastocyst Biopsy on Postnatal Growth in Children Born After Preimplantation Genetic Testing
ClinicalTrials.gov ID: NCT07349966
Acronym / sponsor ID: BABYPGT
Conditions: Preimplantation Genetic Testing (PGT), Frozen Embryo Transfer Cycle, Assisted Reproduction Technologies, Postnatal Health
Keywords: ART, PGT, FET
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 330 participants (estimated)
Lead sponsor: IRCCS San RaffaeleUniversity, hospital or other
Study start: 19 Mar 2026 (actual)
Primary completion: 27 Oct 2028 (estimated)
Study completion: 27 Oct 2028 (estimated)
First posted: 20 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Prospective
Target follow-up: 1 Day
Number of arms: 2

Arm	Type	Receives
Cases	–	Other: Questionnaire110 children born as single live births after their mothers underwent a PGT cycle followed by frozen embryo transfer (FET).
Controls	–	Other: Questionnaire220 children born as single live births after their mothers underwent only FET.

Who may qualify

Ages: Up to 60 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child
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.

Key inclusion criteria (16 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QuestionnaireThe 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).	Other	Cases, Controls

Primary outcome

Impact of Blastocyst Biopsy on Postnatal Growth at One Year
Time frame: 12 months of life of children
Questionnaire

1 secondary outcome

Long-Term Growth After Blastocyst Biopsy
Time frame: At birth of children and at 60 months of age

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
Background: PubMed 35219589Alteri 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.
Background: PubMed 36655536Alteri 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.
Background: PubMed 17947786von 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.
Background: PubMed 34373103Hou 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.
Background: PubMed 27063603Magnus 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.
Background: PubMed 32851407Ong 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.
Background: PubMed 30258309Waynforth 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.
Background: PubMed 34473268Zheng 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.
Individual participant dataSharing planned: No

Related trials for Preimplantation Genetic Testing (PGT)

Active, not recruitingObservational study
Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Couples With Non-obstructive Azoospermia (NOA)
Non-obstructive Azoospermia, Male Infertility
Not yet recruitingObservational study
Prospective International Multi-center Clinical Trial of PGT-A Upgrade
Infertility Assisted Reproductive Technology
Not yet recruitingPhase 3
Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT-A
Preimplantation Genetic Testing, Progestin-primed Ovarian Stimulation
Enrolling by invitationObservational study
Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing
Infertility, Female, Infertility, Male
Active, not recruiting
To Investigate if the Harvester® Improves Sperm Motility and Blastocyst Utilization (the Percent of Fertilized Eggs That Develop to the Point That They Are Able to be Transferred) in IVF Cycles.
Infertility, Male Infertility

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

ENRICO PAPALEO, MD principal investigator

IRCCS San Raffaele

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Preimplantation Genetic Testing (PGT) and Frozen Embryo Transfer Cycle, run by IRCCS San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of Blastocyst Biopsy on Postnatal Growth at One Year (time frame: 12 months of life of children). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07349966, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.