Hysteroscopic correction of uterine malformations to improve pregnancy and childbirth outcomes
Surgical and Obstetric Outcomes in Patients With Uterine Malformations Undergoing Hysteroscopic Corrective Treatment
This project will see if hysteroscopic correction of uterine malformations helps women with infertility become pregnant within 12 months after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT06610864 on ClinicalTrials.gov |
What this trial studies
This is an observational cohort of adult women who underwent hysteroscopic corrective surgery for uterine malformations at the participating center, with outcomes compared before and after the procedure. The primary outcome is pregnancy rate at 12 months after surgery, and secondary outcomes include first- and second-trimester spontaneous abortion rates, live birth rate, and changes in dyspareunia and dysmenorrhea. Researchers will also analyze patient, histopathological, and surgical factors associated with obstetric outcomes. Data will be obtained from medical records and follow-up clinical visits to characterize reproductive and symptomatic changes after hysteroscopic metroplasty.
Who should consider this trial
Good fit: Women aged 18 or older with uterine malformations who undergo hysteroscopic corrective surgery and do not have other known causes of infertility are the ideal candidates.
Not a fit: Women whose infertility is explained by other known causes, those under 18, or those whose uterine anomaly cannot be corrected by hysteroscopy are unlikely to gain benefit.
Why it matters
Potential benefit: If successful, hysteroscopic correction could increase pregnancy and live birth rates and reduce miscarriage and pelvic pain for women with certain uterine malformations.
How similar studies have performed: Previous surgical series and observational studies suggest hysteroscopic metroplasty can improve pregnancy rates and reduce miscarriage for septate uterus, but randomized trials are limited and results vary by anomaly type.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome, RM
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Rm, Italy (Recruiting)
Study contacts
- Principal investigator: Ursula Catena — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Ursula Catena
- Email: ursula.catena@policlinicogemelli.it
- Phone: 3382760021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.