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

NCT06893978 | Not Yet Recruiting

• 1 other identifier: 7203
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Pregnancy Loss; Preterm Birth; Healthy

Outcome Measures

Primary Outcomes (3)

• Development of placental 3D organoid model

  Morphological characteristics of placental 3D organoids successfully developed from placentas obtained from full-term physiological pregnancies and pathological conditions (abortion, preeclampsia, preterm delivery). Assessment Parameters: Organoid formation efficiency (%)

  From the date of caesarean section until the development of placental organoids, assessed up to 36 months.

• Characterization of placental 3D organoid model

  Assessment of cell viability (live/dead staining)

  From the date of caesarean section until the development of placental organoids, assessed up to 36 months.

• Viability of Placental Organoids

  Measurement of cell proliferation rate in normal and pathological placental organoids before and after anticoagulant, anti-inflammatory, and immunomodulatory treatments (heparin, aspirin, metformin, IVIg, filgrastim). Assessment Parameters: Cell viability (live/dead staining)

  From date of caesarean section until the development of placental organoids, until 36 months

Secondary Outcomes (5)

• Gene Expression in Placental Organoids

  From date of caesarean section until the development of placental organoids, until 36 months

• Secretome Analysis of Placental Organoids

  From date of caesarean section until the development of placental organoids, until 36 months

• Proliferative Capacity of Placental Organoids

  From date of caesarean section until the development of placental organoids, until 36 months

• Growth capacity of placental organoids

  From date of caesarean section until the development of placental organoids, until 36 months

• Protein expression in placental organoids

  From date of caesarean section until the development of placental organoids, until 36 months

Interventions

Placenta organoids treatment DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with normal pregnancy (n=5) or complicated by: * miscarriage (n=5); * preeclampsia (n=5); * preterm delivery (n=5); afferent to the U.O.C. of Obstetrics of the Agostino Policlinico Universitario Agostino Gemelli IRCCS of Rome.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

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

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Pre-Eclampsia; Premature Birth

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Chiara Tersigni, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Tersigni

CONTACT

+390630157546; chiara.tersigni@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: March 25, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 20, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)