ClinConnect ClinConnect Logo
Search / Trial NCT06610864

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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Sep 20, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Uterine Malformation Hysteroscopic Metroplasty Reproductive Outcomes

ClinConnect Summary

This clinical trial is studying whether a specific type of surgery called hysteroscopic correction can help improve pregnancy outcomes for women with uterine malformations, which are conditions where the uterus doesn't develop normally. The researchers want to find out if this surgery can lead to more pregnancies after one year, reduce the chances of miscarriage, increase the number of live births, and help with related symptoms like pain during intercourse or menstruation.

To be eligible for this study, women must be at least 18 years old and have undergone hysteroscopic correction for uterine malformations at certain hospitals in Italy. The study will look at the health and pregnancy outcomes of these women before and after their surgery to see how effective the treatment is. Participants will be expected to provide their medical information for analysis, and the study is not yet recruiting participants.

Gender

FEMALE

Eligibility criteria

  • 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.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Rome, Rm, Italy

Patients applied

0 patients applied

Trial Officials

Ursula Catena

Principal Investigator

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported