NCT06610864

Surgical and Obstetric Outcomes in Patients With Uterine Malformations Undergoing Hysteroscopic Corrective Treatment

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational cohort study is to learn if hysteroscopic correction can improve reproductive outcomes in women with uterine malformations. The main questions it aims to answer are: Primary hypothesis: -Does hysteroscopic correction significantly improve pregnancy rates at 12 months post-surgery in women with uterine malformations? Secondary hypotheses: * Does hysteroscopic correction significantly reduce the rate of first and second-trimester spontaneous abortions? * Does hysteroscopic correction significantly increase the live birth rate? * In symptomatic patients, does hysteroscopic correction significantly reduce dyspareunia and dysmenorrhea? * Which patient, histopathological, and surgical factors are associated with improved obstetric outcomes? Researchers will compare obstetric outcomes (pregnancy rate, spontaneous abortion rate, live birth rate, and symptom severity) before and after hysteroscopic correction to determine the effectiveness of this surgical intervention. Participants will be women with uterine malformations who underwent hysteroscopic correction at the Digital Hysteroscopy Center of Policlinico Universitario A. Gemelli di Roma and Azienda Ospedaliera Universitaria Federico II di Napoli. Data will be retrospectively collected and analyzed to assess the impact of surgery on reproductive outcomes.

Conditions

• Malformation
• Female Infertility
• Hysteroscopy Surgery

Timeline

• Start date: 2024-10-11
• Primary completion: 2025-02-01
• Completion: 2025-10-11
• First posted: 2024-09-24
• Last updated: 2025-08-05

Locations

1 site across 1 country: Italy