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SCRaTCH

Does endometrial scratching in women with implantation failure after a first IVF/ICSI cycle lead to lower costs due to a reduction in the number of subsequent IVF/ICSI cycles needed to achieve a live birth? 

Go to the SCRaTCH website.

Objective
The primary objective is to test the hypothesis that endometrial scratching in the cycle preceding controlled ovarian stimulation in women with implantation failure (defined as failure to achieve an ongoing implantation after having completed a full first ART cycle with at least one embryo replaced) is more cost effective compared to no scratching due to a reduction in the number of subsequent IVF/ICSI cycles needed to achieve a live birth.

Study design
Multicenter randomized controlled trial with cost-effectiveness analysis 

Study population
Women with implantation failure after a first full IVF/ICSI cycle.

Intervention
Endometrial scratch 5 to 10 days before an expected bleed in a natural or oral contraceptive cycle, directly before starting a second IVF/ICSI cycle

Outcome measures
Primary: Ongoing pregnancy leading to live birth after the second fresh IVF/ICSI cycle. Secondary: Cumulative live birth after the full second IVF/ICSI cycle (fresh+frozen), cumulative live birth after 12 months of IVF/ICSI treatment (fresh+frozen), cycle cancellation, miscarriage rate, twin birth rate, costs.

Power/data analysis
The difference in live birth rate after the second full ART cycle is estimated to be 8% between the patients with and without endometrial scratch (38% versus 30%). The number of patients needed to have 80% power (with alpha = 0.05) to detect such a difference is 450 per study arm (900 in total). This number takes into account the possibility that randomized women will drop out from the study based on withdrawal of consent, spontaneous pregnancy before the ART cycle is initiated or failure to complete the scratching procedure. Taken together the dropout rate for these reasons is estimated to be 3%.

Time schedule
Inclusion is expected to take 30 months

Projectleaders
Dr. H.L. Torrance, MD PhD
Prof. dr. F. Broekmans, MD PhD
UMC Utrecht

Subsidy
ZonMW project 843002601

Contact
Dr. H.L. Torrance MD PhD
UMC Utrecht
088-7551443
h.torrance@umcutrecht.nl