Clinical trial NCT06610864: Surgical and Obstetric Outcomes in Patients with Uterine Malformations Undergoing Hysteroscopic Corrective Treatment
Official title: Surgical and Obstetric Outcomes in Patients with Uterine Malformations Undergoing Hysteroscopic Corrective Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Malformation
Female Infertility
Hysteroscopy Surgery
Keywords: uterine malformation
hysteroscopic metroplasty
reproductive outcomes
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Pregnancy rates
timeFrame: From January 2021 to December 2023
Secondary outcomes:
measure: Abortion rate
timeFrame: From January 2021 to December 2023
measure: Live birth rate
timeFrame: From January 2021 to January 2023
measure: Symptoms resolution
timeFrame: From January 2021 to December 2023
measure: Prognostic factors
timeFrame: From January 2021 to December 2023
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Ursula Catena
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.