Surgical and Obstetric Outcomes in Patients With Uterine Malformations Undergoing Hysteroscopic Corrective Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Pregnancy rates
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with known, concurrent causes of infertility.
- •Patients who did not provide informed consent to participate in the study.
- •Age younger than 18 years.
结局指标
主要结局
Pregnancy rates
时间窗: 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
次要结局
- 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)
研究者
Catena Ursula
Doctor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS