NCT06610864 Surgical and Obstetric Outcomes in Patients With Uterine Malformations Undergoing Hysteroscopic Corrective Treatment
| NCT ID | NCT06610864 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Malformation |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-10-11 |
| Primary Completion | 2025-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-10-11 with a primary completion date of 2025-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Women who underwent hysteroscopy at the Class Hysteroscopy Center of Policlinico Universitario A. Gemelli di Roma or Azienda Ospedaliera Universitaria Federico II di Napoli for the correction of uterine malformations, including partial, complete, and septate bicornuate uteri, dysmorphic uteri, with or without associated cervical and/or vaginal septa (ESHRE-ESGE classification: U1a and U1c; U2a, U2b, and U3c with or without associated cervical or vaginal anomalies C1/2 or V1/2). * Age 18 years or older. Exclusion Criteria: * Patients with known, concurrent causes of infertility. * Patients who did not provide informed consent to participate in the study. * Age younger than 18 years.
Contact & Investigator
Ursula Catena
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06610864 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Malformation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06610864 currently recruiting?
Yes, NCT06610864 is actively recruiting participants. Contact the research team at ursula.catena@policlinicogemelli.it for enrollment information.
Where is the NCT06610864 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06610864 clinical trial?
NCT06610864 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Ursula Catena at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 300 participants.