How cesarean scar defects affect success of assisted reproduction
The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction: The Prospective NICHE-ART Study
This project will see if a cesarean scar defect (isthmocele) changes chances of pregnancy and live birth for women having IVF or ICSI after a prior cesarean.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 43 Years |
| Sex | Female |
| Sponsor | University Hospital, Angers Government |
| Locations | 9 sites (Angers and 8 other locations) |
| Trial ID | NCT04869007 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective observational study groups women with prior cesarean sections into those with and without an isthmocele, defined as residual myometrial thickness <3 mm on hysterosonography. Eligible participants are women aged 18–43 with secondary infertility planning ART (IVF or ICSI) who receive routine pre-ART hysterosonography. Clinical pregnancy is defined as an intrauterine gestational sac with cardiac activity at 7 weeks after embryo transfer, and outcomes including clinical pregnancy and live birth will be compared between the isthmocele+ and isthmocele- groups. Sociodemographic and medical history data are collected at the initial ART consultation and specific hysterosonography measurements are performed per protocol.
Who should consider this trial
Good fit: Women aged 18–43 with at least one prior cesarean section, secondary infertility requiring IVF or ICSI, who undergo pre-ART hysterosonography and are French-speaking with social security coverage.
Not a fit: Women without a prior cesarean, those with primary infertility not pursuing ART, those older than 43, or patients who do not undergo hysterosonography are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the results could help clinicians personalize pre-ART care by identifying patients who might benefit from targeted evaluation or treatment of cesarean scar defects to improve IVF outcomes.
How similar studies have performed: Smaller observational studies and case series have linked isthmoceles to infertility and reported improved outcomes after surgical repair, but rigorous multicenter data on ART success are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria : * Patients with a history of at least one cesarean section (single or multi-scarred uterus). * Age between 18 and 43 years old * Secondary infertility requiring ART techniques (FIV or FIV ICSI). * A Hysterosonography examination as part of the pre-ART assessment allowing for the detection of the presence of an isthmocele. * French speaking patients * Patient affiliated to or beneficiary of a social security scheme Non-inclusion criteria : \- Refusal to participate in the study.
Where this trial is running
Angers and 8 other locations
- UH Angers — Angers, France (Recruiting)
- University Hospital of Brest — Brest, France (Recruiting)
- Hospital Center Sud Francilien — Corbeil-Essonnes, France (Recruiting)
- Creteil University Hospital — Créteil, France (Recruiting)
- University Hospital of Nimes — Nîmes, France (Recruiting)
- Tenon Hospital Paris — Paris, France (Recruiting)
- La Sagesse Clinic — Rennes, France (Recruiting)
- University Hospital of Rennes — Rennes, France (Recruiting)
- University Hospital of Saint Etienne — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: Guillaume LEGENDRE, MD PhD — UH Angers
- Study coordinator: Guillaume LEGENDRE, MD PhD
- Email: guillaume.legendre@chu-angers.fr
- Phone: 024154459
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.