Actively Recruiting
Surgical and Obstetric Outcomes in Patients With Uterine Malformations Undergoing Hysteroscopic Corrective Treatment
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-05
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Surgical and Obstetric Outcomes in Patients With Uterine Malformations Undergoing Hysteroscopic Corrective Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women who had hysteroscopy at the Class Hysteroscopy Center of Policlinico Universitario A. Gemelli di Roma or Azienda Ospedaliera Universitaria Federico II di Napoli for uterine malformation correction
- Uterine malformations include partial, complete, and septate bicornuate uteri, dysmorphic uteri, with or without cervical and/or vaginal septa (ESHRE-ESGE classification U1a, U1c, U2a, U2b, U3c, with or without anomalies C1/2 or V1/2)
- Age 18 years or older
You will not qualify if you...
- Known, concurrent causes of infertility
- No informed consent provided for study participation
- Age younger than 18 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, RM, Italy, 00168
Actively Recruiting
Research Team
U
URSULA CATENA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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