Placental Organoids Development: Application in the Study of the Human Reproduction Pathophysiology.

NCT ID: NCT06893978

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2027-11-30

Brief Summary

Placental organoids represent an in vitro 3D reconstruction model of the human placenta and of its complex cellular organization to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics.

Detailed Description

Placental organoids represent an in vitro 3D reconstruction model of the human placenta and of its complex cellular organization. Placental organoid model can be used in the study of placental pathophysiology. In in particular, it provides a personalized model for sartorial in vitro evaluation of personalized therapeutic efficacy of different pharmacological therapies. In particular, with placental organoid it is possible to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics.

Conditions

Preeclampsia; Pregnancy Loss; Preterm Birth; Healthy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Interventions

Placenta organoids treatment

Placenta organoids in vitro treatment with heparin, aspirin, IVIG, filgrastim and metformin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Women with uncomplicated normal term pregnancy undergoing elective cesarean section for previous uterine surgery or breech presentation of the fetus;
• Patients with retained abortion and history of recurrent abortion sine causa at the end of the work-up of investigations performed according to ESHRE guidelines, undergoing revision of the uterine cavity;
• Patients diagnosed with preeclampsia, defined in accordance with the definitions of ISSHP, undergoing cesarean section;
• Patients with preterm onset, before 37 weeks gestational age, of spontaneous labor, undergoing cesarean section in labor for low weight or abnormal fetal presentation.

Exclusion Criteria

• Age <18 years;
• Chronic infection with HIV or HCV;
• Ongoing malignant neoplasms;
• Multiple pregnancies;
• Inability to provide informed informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chiara Tersigni, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica

Rome, Lazio, Italy

Countries

Italy

Central Contacts

Chiara Tersigni

Role: CONTACT

chiara.tersigni@policlinicogemelli.it

+390630157546

Facility Contacts

Chiara Tersigni

Role: primary

chiara.tersigni@policlinicogemelli.it

+390630157546

Other Identifiers

7203

Identifier Type: -

Identifier Source: org_study_id