Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06346418

Maternal Genes and Epimutations: Beckwith-Wiedemann Syndrome & Reproductive Risks

Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2025-05-02

208

Participants Needed

2

Research Sites

136 weeks

Total Duration

On this page

Sponsors

F

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Lead Sponsor

I

Istituto Auxologico Italiano

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pathogenic variants in subcortical maternal complex (SCMC) have been identified not only in mothers of Beckwith-Wiedemann syndrome (BWS) babies but also in women with reproductive disturbances such as failed pregnancy attempts and recurrent pregnancy loss. Based on the higher incidence of BWS in children born from Assisted Reproductive Technology (ART), this project aims to investigate incidence and molecular mechanism of pathogenic variants of SCMC in women with reproductive disorders. Study objectives will be (i) assess the incidence of these variants as a cause of differences in reproductive outcomes in the infertile female population and mothers of children with BWS; (ii) identify methylation changes in women with reproductive problems including those with offspring affected by BWS; (iii) determine the molecular causes underlying female infertility and imprinting disorder associated with damaging SCMC gene variants by employing a mouse model.

CONDITIONS

Official Title

Maternal Genes and Epimutations: Beckwith-Wiedemann Syndrome & Reproductive Risks

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy women with a child affected by Beckwith-Wiedemann syndrome and specific reproductive history
  • Women under 35 undergoing assisted reproductive technology for infertility, defined as failure to conceive after 12 months of regular unprotected sex and no live birth after three cycles or transfer of at least 6 blastocysts
  • Women under 35 with recurrent pregnancy loss, defined as losing two or more pregnancies before 24 weeks gestation
Not Eligible

You will not qualify if you...

  • Presence of conventional or molecular karyotype alterations
  • Known causes of decreased fertility or recurrent abortions such as ovarian disorders (e.g., polycystic ovarian syndrome), endocrine system imbalances, autoimmune conditions, male infertility, uterine or tubal dysfunctions or malformations
  • Thrombophilic conditions or untreated thyroid dysfunctions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy, 20122

Actively Recruiting

2

Istituto Auxologico Italiano

Milan, Italy, 20145

Actively Recruiting

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Research Team

E

Edgardo Somigliana, PhD

CONTACT

M

Marco Reschini, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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