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

August 4, 2025 updated by: Catena Ursula, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
        • Contact:
        • Principal Investigator:
          • Ursula Catena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Women with uterine malformations
Women with uterine malformations who underwent hysteroscopic correction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rates
Time Frame: 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
From January 2021 to December 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abortion rate
Time Frame: From January 2021 to December 2023
To compare rates of first and second-trimester spontaneous abortions before and after hysteroscopic correction
From January 2021 to December 2023
Live birth rate
Time Frame: From January 2021 to January 2023
To compare live birth rates before and after hysteroscopic correction.
From January 2021 to January 2023
Symptoms resolution
Time Frame: 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
From January 2021 to December 2023
Prognostic factors
Time Frame: 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.
From January 2021 to December 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Ursula Catena, Fondazione Policlinico Universitario A. gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2024

Primary Completion (Actual)

February 1, 2025

Study Completion (Estimated)

October 11, 2025

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

August 5, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6716

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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