No registrations found.
ID
Source
Brief title
Health condition
- Niche
- Cesarean section scar defect
- Secondary subfertility
- Laparoscopy
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time to ongoing pregnancy, defined as a intrauterine pregnancy with a fetal heartrate at 12 weeks gestation.
Secondary outcome
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.
Background summary
A niche is a defect that can develop at the site a caesarean section scar. A niche can cause complaints of abnormal uterine blood loss, dysmenorrhea, chronic pelvic pain and is related to infertility. Several innovative surgical therapies have been developed to treat niche related symptoms. A laparoscopic resection of the niche is preferred in a large (residual myometrium ≤3mm) symptomatic niche. Reduction of symptoms and promising reproductive outcomes at a low complication rate have been reported in a few case series and cohort studies.
Objective of the study:
The aim of the study is to evaluate the effect of a laparoscopic niche resection in patients with secondary unexplained subfertility or failed IVF in comparison to expectant management on fertility, pregnancy outcome and postmenstrual spotting. Cost-effectiveness analysis will be executed alongside the study.
Study objective
A niche is a defect that can develop at the site a caesarean section scar. A niche can cause complaints of abnormal uterine blood loss, dysmenorrhea, chronic pelvic pain and is related to infertility. Several innovative surgical therapies have been developed to treat niche related symptoms. A laparoscopic resection of the niche is preferred in a large (residual myometrium <3mm) symptomatic niche. Reduction of symptoms and promising reproductive outcomes at a low complication rate have been reported in a few case series and cohort studies.
Study design
- 3, 6, 12 months
- follow up during pregnancy
- follow-up: 2 years
Intervention
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, according to the local protocol.
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6350 |
| NTR-old | NTR6534 |
| CCMO | NL57660.029.16 |
| OMON | NL-OMON50195 |