Female Infertility, Hysteroscopy Surgery, Malformation
Conditions
Keywords
uterine malformation, hysteroscopic metroplasty, reproductive outcomes
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.
Interventions
None listed
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rates | From January 2021 to December 2023 | To compare pregnancy rates (number of clinical pregnancies including live births, abortions and fetal deaths) before and after hysteroscopic correction in women with uterine malformations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abortion rate | From January 2021 to December 2023 | To compare rates of first and second-trimester spontaneous abortions before and after hysteroscopic correction |
| Live birth rate | From January 2021 to January 2023 | To compare live birth rates before and after hysteroscopic correction. |
| Symptoms resolution | From January 2021 to December 2023 | In a subgroup of symptomatic patients, to assess the impact of hysteroscopic correction on the reduction of dyspareunia and dysmenorrhea |
| Prognostic factors | From January 2021 to December 2023 | To identify potential prognostic factors, including medical history, histopathology, and surgical factors, associated with improved obstetric outcomes following hysteroscopic correction. |
Countries
Italy
Contacts
Primary ContactURSULA CATENA
Outcome results
None listed