Surgical and Obstetric Outcomes in Patients With Uterine Malformations Undergoing Hysteroscopic Corrective Treatment

Not yet recruiting

• Conditions: Malformation; Female Infertility; Hysteroscopy Surgery

• Registration Number: NCT06610864
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Study Start: 2024-10-11
• Primary Completion: 2025-02-01
• Study Completion: 2025-10-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, RM, Italy