Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with uterine malformations | Women with uterine malformations who underwent hysteroscopic correction. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rates | 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 | From January 2021 to December 2023 |
| Measure | Description | Time Frame |
|---|---|---|
| Abortion rate | To compare rates of first and second-trimester spontaneous abortions before and after hysteroscopic correction | From January 2021 to December 2023 |
| Live birth rate | To compare live birth rates before and after hysteroscopic correction. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study population will consist of women who underwent hysteroscopic correction for uterine malformations at the Class Hysteroscopy Center of Policlinico Universitario A. Gemelli di Roma or Azienda Ospedaliera Universitaria Federico II di Napoli. These malformations include partial, complete, and septate bicornuate uteri, dysmorphic uteri, with or without associated cervical and/or vaginal septa. Patients will be identified retrospectively through a review of medical records and will be contacted via telephone to obtain informed consent for participation in the study. Data will be collected retrospectively from medical records and through semi-annual follow-up telephone calls over a 12-month period.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| URSULA CATENA | Contact | 3382760021 | ursula.catena@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Ursula Catena | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Recruiting | Rome | RM | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34648934 | Result | 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. | |
| 11284660 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
| From January 2021 to January 2023 |
| Symptoms resolution | In a subgroup of symptomatic patients, to assess the impact of hysteroscopic correction on the reduction of dyspareunia and dysmenorrhea | From January 2021 to December 2023 |
| Prognostic factors | To identify potential prognostic factors, including medical history, histopathology, and surgical factors, associated with improved obstetric outcomes following hysteroscopic correction. | From January 2021 to December 2023 |
| 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. |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |