Role of Maternal Effect Genes and Epimutations in Beckwith-Wiedemann Syndrome and Adverse Reproductive Outcomes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Cohort 1: healthy women with offspring affected by BWS and peculiar reproductive history from our population of clinically and molecularly diagnosed BWS families;

• Cohort 2: women under 35 undergoing ART for infertility (defined as failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourses) and unable to obtain a live birth after three completed cycles or after the transfer of at least 6 blastocysts;

• Cohort 3: women under 35, with RPL (defined as the loss of two or more pregnancies before 24 weeks of gestation).

Locations
Other Locations
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Istituto Auxologico Italiano
RECRUITING
Milan
Contact Information
Primary
Edgardo Somigliana, PhD
edgardo.somigliana@policlinico.mi.it
+390255034303
Backup
Marco Reschini, MSc
marco.reschini@policlinico.mi.it
+390255034303
Time Frame
Start Date: 2023-05-19
Estimated Completion Date: 2026-01
Participants
Target number of participants: 208
Treatments
Experimental: healthy women with offspring affected by BWS
healthy women with offspring affected by BWS and peculiar reproductive history from our population of clinically and molecularly diagnosed BWS families
Experimental: women under 35 undergoing ART
women under 35 undergoing ART for infertility (defined as failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourses) and unable to obtain a live birth after three completed cycles or after the transfer of at least 6 blastocysts
Experimental: women under 35, with RPL
women under 35, with RPL (defined as the loss of two or more pregnancies before 24 weeks of gestation)
Sponsors
Collaborators: Federico II University, Istituto Auxologico Italiano, University of Campania Luigi Vanvitelli
Leads: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

This content was sourced from clinicaltrials.gov