Surgical and Obstetric Outcomes in Patients With Uterine Malformations Undergoing Hysteroscopic Corrective Treatment
NCT ID: NCT06610864
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-10-11
2025-10-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Women with uterine malformations
Women with uterine malformations who underwent hysteroscopic correction.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older.
Exclusion Criteria
* Patients who did not provide informed consent to participate in the study.
* Age younger than 18 years.
18 Years
FEMALE
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Catena Ursula
Principal Investigator
Principal Investigators
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Ursula Catena
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
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Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, RM, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Carrera M, Perez Millan F, Alcazar JL, Alonso L, Caballero M, Carugno J, Dominguez JA, Moratalla E. Effect of Hysteroscopic Metroplasty on Reproductive Outcomes in Women with Septate Uterus: Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2022 Apr;29(4):465-475. doi: 10.1016/j.jmig.2021.10.001. Epub 2021 Oct 11.
Grimbizis GF, Camus M, Tarlatzis BC, Bontis JN, Devroey P. Clinical implications of uterine malformations and hysteroscopic treatment results. Hum Reprod Update. 2001 Mar-Apr;7(2):161-74. doi: 10.1093/humupd/7.2.161.
Other Identifiers
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6716
Identifier Type: -
Identifier Source: org_study_id
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