None listed
Conditions
Interventions
Laparoscopic niche resection, contraceptives during the first 6 months to enable healing of the uterine scar before a pregnancy is allowed, thereafter fertility therapies are allowed if needed, accord
Sponsors
VU medical center
Eligibility
Inclusion criteria
Inclusion criteria: Women (>18 years) with the presence of a large niche and secondary unexplained subfertility, failed IVF, or with problems during their fertility therapy, such as intrauterine accumulation of fluid and/ or difficulties during the introduction of the ET of IU catheter will be included.
Exclusion criteria
Exclusion criteria: Pregnancy, age < 18 years, contraindications for general anaesthesia, a (suspected) malignancy, uterine of cervical polyps, submucosal fibroids, atypical endometrial cells, cervical dysplasia, cervical or pelvic infection, hydrosalphinx.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to ongoing pregnancy, defined as a intrauterine pregnancy with a fetal heartrate at 12 weeks gestation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fertility and pregnancy outcomes, satisfaction and quality of life, surgical outcomes (intervention group), additional interventions, niche characteristics. Economic evaluation: direct and indirect costs will be executed from a social perspective. | — |
Contacts
Public ContactJ.A.F. Huirne
Outcome results
None listed