The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction: The Prospective NICHE-ART Study

What this Trial Is About

Cesarean sections have been increasing worldwide, raising the risk of obstetrical complications such as uterine defects called isthmoceles. These defects involve scarring with thinning of the uterine wall and may cause symptoms like abnormal bleeding or pelvic pain. This study aims to explore how a significant isthmocele, defined by a residual myometrial thickness of less than 3 mm measured by hysterosonography, might affect the success rates of assisted reproductive technologies (ART) in women with a history of cesarean section. The study is observational, multicentric, and prospective, enrolling women with previous cesarean sections undergoing ART. Participants undergo a hysterosonography to detect the presence or absence of an isthmocele, and then are grouped accordingly. Researchers will collect data during the ART treatment process including ovarian stimulation, embryo transfer, and pregnancy tests. The study does not involve surgical intervention but focuses on the measurement and impact of isthmoceles detected by ultrasound. Participants attend scheduled ART consultations where medical history, examinations, and hysterosonography are performed. Blood tests for pregnancy hormone levels and ultrasound scans are conducted after embryo transfer to monitor pregnancy progress. Delivery data are collected when possible either from hospital records or follow-up phone calls. The main outcome is the clinical pregnancy rate at 12 months, defined by ultrasound confirmation of a viable pregnancy. Secondary outcomes include other IVF success criteria related to isthmocele presence. The study duration allows for comprehensive monitoring of fertility outcomes after ART.

The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction