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LAPRESS study


- candidate number26732
- NTR NumberNTR6534
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-feb-2017
- Secondary IDsNL57660.029.16. METC 2017.030
- Public TitleLAPRESS study
- Scientific TitleThe 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.
- ACRONYMLAPRESS study
- hypothesisA 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.
- Healt Condition(s) or Problem(s) studiedNiche, Laparoscopy, Caesarean section, Cesarean scar defect , Subfertility
- Inclusion criteriaWomen (>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 criteriaPregnancy, 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2017
- planned closingdate1-jan-2021
- Target number of participants200
- InterventionsLaparoscopic 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.
- Primary outcomeTime to ongoing pregnancy, defined as a intrauterine pregnancy with a fetal heartrate at 12 weeks gestation.
- Secondary outcomeFertility 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.
- Timepoints- 3, 6, 12 months
- follow up during pregnancy
- follow-up: 2 years
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.A.F. Huirne
- CONTACT for SCIENTIFIC QUERIESDrs. J. Vissers
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryA 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.
- Main changes (audit trail)
- RECORD20-feb-2017 - 15-jul-2017


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