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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?


- candidate number22526
- NTR NumberNTR5342
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-jul-2015
- Secondary IDsNL54552.041.15 
- Public TitleDoes 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?
- Scientific TitleDoes 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?
- ACRONYMSCRaTCH
- hypothesisThe inflammatory response to iatrogenic superficial trauma to the endometrial lining will enable the endometrium to acquire a state of optimal receptivity thereby positively affecting live birth rates.
- Healt Condition(s) or Problem(s) studiedInfertility, IVF, Endometrium
- Inclusion criteria1. Female age 18-43 years
2. Implantation failure (IF) defined as the absence of an ongoing pregnancy occurring after a full first ART cycle, where at least one embryo has been transferred, in either the fresh or subsequent frozen/thaw cycles
3. Must be planning a second full IVF/ICSI cycle
4. Primary or secondary infertility
5. Normal transvaginal ultrasound, defined as no visible intracavitary pathology or intramural myomas with impression of the uterine cavity
6. Written informed consent
- Exclusion criteria1. History of lower abdominal or pelvic infection
2. Higher chance of intra-abdominal infection due to intestinal surgery (for for instance Crohn’s disease or colitis)
3. Endometriosis grade 3 and 4
4. Previous caesarean section with niche formation
5. The presence of untreated unilateral or bilateral hydrosalpinx
6. Previous endometrial scratching
7. Meno-metrorrhagia (defined as any intermenstrual loss of blood)
8. Oocyte donation cycles
9. Medical contra-indication for IVF/ICSI
10. Untreated/unsubstituted endocrine abnormalities (e.g. pituitary, thyroid, adrenal or pancreas)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2016
- planned closingdate15-dec-2019
- Target number of participants900
- InterventionsEndometrial scratch in the luteal phase of the cycle preceding the 2nd IVF/ICSI cycle
- Primary outcomeOngoing pregnancy leading to live birth after the second fresh ART cycle
- Secondary outcome- Cumulative live birth after the second fresh and subsequent frozen/thaw transfer cycles
- Cumulative live birth after a 12 months IVF/ICSI treatment period (i.e. including all initiated fresh and frozen/thaw transfer cycles performed in that period)
- Miscarriage rate
- Twin birth rate
- Costs
- Endometrial tissue parameters associated with implantation failure
- Timepoints12 months of FU
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Helen Torrance
- CONTACT for SCIENTIFIC QUERIES Helen Torrance
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, University Medical Center Utrecht (UMCU)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD31-jul-2015 - 23-dec-2015


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