APRESS study
- Conditions
- - Niche- Cesarean section scar defect- Secondary subfertility- Laparoscopy
- Registration Number
- NL-OMON28650
- Lead Sponsor
- VU medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 200
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to ongoing pregnancy, defined as a intrauterine pregnancy with a fetal heartrate at 12 weeks gestation.
- Secondary Outcome Measures
Name Time Method Fertility and pregnancy outcomes, satisfaction and quality of life, surgical outcomes (intervention group), additional interventions, niche characteristics.<br /><br>Economic evaluation: direct and indirect costs will be executed from a social perspective.