The effectiveness of laparoscopic niche resection versus expectant management in patients with secondary subfertility and a large uterine caesarean scar defect (niche) on reproductive outcomes, a randomised controlled trial.

Recruiting

Conditions: CS scar defect
Isthmocele
10013356

Registration Number: NL-OMON50195

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: time to ongoing pregnancy, defined as a intrauterine pregnancy<br /><br>with a fetal heartrate at 12 weeks gestation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes: Fertility and pregnancy outcomes, satisfaction and quality<br /><br>of life, surgical outcomes (intervention group), additional interventions,<br /><br>niche characteristics.<br /><br>Economic evaluation: direct and indirect costs will be executed from a social<br /><br>perspective.</p><br>