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

NCT06610864 | Recruiting

• 1 other identifier: 6716
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Malformation; Female Infertility; Hysteroscopy Surgery

Keywords

uterine malformation; hysteroscopic metroplasty; reproductive outcomes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Abortion rate

  From January 2021 to December 2023

• Live birth rate

  From January 2021 to January 2023

• Symptoms resolution

  From January 2021 to December 2023

• Prognostic factors

  From January 2021 to December 2023

Study Arms (1)

Women with uterine malformations

Women with uterine malformations who underwent hysteroscopic correction.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with known, concurrent causes of infertility.
• Patients who did not provide informed consent to participate in the study.
• Age younger than 18 years.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, RM, 00168, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 34648934 BACKGROUND

• 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.

  PMID: 11284660 BACKGROUND

MeSH Terms

Conditions

Congenital Abnormalities; Infertility, Female

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Ursula Catena

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

URSULA CATENA

CONTACT

3382760021; ursula.catena@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: October 11, 2024
• Primary Completion: February 1, 2025
• Study Completion: October 11, 2025
• Last Updated: August 5, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)