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

Study acronym: MAL_CO
StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    • Publications: details revised at 2 of 2 entries
    v3
  3. Site contact updated
    • Publications: details revised at 2 of 2 entries
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06610864
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions
(from sponsor)		 Malformation, Female Infertility, Hysteroscopy Surgery
Related terms Congenital Abnormalities, Infertility, Female
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov