Surgical and Obstetric Outcomes in Patients with Uterine Malformations Undergoing Hysteroscopic Corrective Treatment (MAL_CO)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Female Infertility; Malformation; Hysteroscopy Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT06610864

6716

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Women with uterine malformations

Description:

Women with uterine malformations who underwent hysteroscopic correction.