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…
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Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: time to ongoing pregnancy, defined as a intrauterine pregnancy
with a fetal heartrate at 12 weeks gestation.
Secondary outcome
Secondary outcomes: 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
In the recent years the number of caesarens has increased significantly. A
niche is a defect that can develop at the site of the 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
niche resection of the niche is an standad treatment in women with a large
symptomatic niche (residual myomterium <3mm). Reduction of symptoms and
promising reproductive outcomes at low complication rate have been reported in
a few case series and cohort studies.
Study objective
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 design
The study is a multicentre randomised controlled trial. Patients will be
randomly allocated to laparoscopic niche resection or expectant management for
9 months.
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.
Study burden and risks
Patients will be informed about the procedure en will be informed that at this
moment there is no evidence about the effectiveness of the procedure. The
procedure will be in a research setting. The risks of laparoscopy include
perforation, infection or bleeding, and very rarely a defect and / or
perforation of the bladder or bowel can occur. Therefore, this procedure is
performed only by gynecologists with enough experience (> 30 previous
laparoscopic resections niche).
In a previous cohort study the procedure is performed 101 patients, a low
complication rate is reported.
Boelelaan 1118
Amsterdam 1081 HZ
NL
Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
Women with the presence of a large niche after CS failed IVF or secondary
unexplained subfertility or problems during their fertility therapy, such as
intrauterine accumulation of fluid and/ or difficulties during the introduction
of the ET of IU catheter and not meeting any of the exclusion criteria are
eligible to be randomised.
Women with a large niche and a wish to conceive in the near future are also
eligble to participate in the study.
Exclusion criteria
Pregnancy, age < 18 years
contraindications for general anaesthesia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL57660.029.16 |
| OMON | NL-OMON28650 |