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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- ISRCTNISRCTN no longer applicable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
- statusopen: patient inclusion
- 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)
- Publicationsvan Hoogenhuijze NE, Torrance HL et al.. Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342). BMC Womens Health. 2017 Jul 21;17(1):47. https://doi.org/10.1186/s12905-017- 0378-y
- Brief summary
- Main changes (audit trail)2-feb-2018 -IK:

Inclusion criteria:
"1. 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"

replaced by

"1. Female age 18-43 years
2. Implantation failure (IF) defined as the absence of a clinical pregnancy occurring after:
a. a full first ART cycle, where at least one embryo has been transferred, in either the fresh or subsequent frozen/thaw cycles
b. a first ART cycle without any embryo transfer (for example due to total fertilization failure), followed by a full second 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 criteria:
"1. 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)"

replaced by

"1. 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. Pre-implantation genetic diagnosis (PGD) cycles
10. Medical contra-indication for IVF/ICSI
11. Untreated/unsubstituted endocrine abnormalities (e.g. pituitary, thyroid, adrenal or pancreas)"


Primary outcome:
"Ongoing pregnancy leading to live birth after the second fresh ART cycle"

replaced by

"Ongoing pregnancy leading to live birth after the fresh ART cycle following randomization. Live birth is defined as the delivery of at least on live foetus after 24 weeks of gestation."


Secondary outcomes:
"- 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"

replaced by

"- Cumulative live birth after the fresh and subsequent frozen/thaw transfer cycles after randomization, of which the ‘ongoing pregnancy’ should be achieved within 12 months after randomization.
- Cumulative live birth after a 12 months IVF/ICSI treatment period, of which the ‘ongoing pregnancy’ should be achieved within 12 months after randomization (i.e. including all initiated fresh and frozen/thaw transfer cycles performed in that period).
- Clinical pregnancy rate (clinical pregnancy achieved within 11 months after randomization. Clinical pregnancy is defined as a gestational sac or ectopic pregnancy visualized on ultrasound.)
- Ongoing pregnancy rate (ongoing pregnancy achieved within 12 months after randomization)
- Implantation rate (defined as number of gestational sacs on the first ultrasound divided by the number of transferred embryo’s, of which the first ultrasound is performed within 11 months after randomization).
- Miscarriage rate (diagnosed within 12 months after randomization, and with miscarriage defined as loss of a clinical pregnancy, excluding procured abortion)
- Biochemical pregnancy rate (defined as positive urinary hCG test or serum hCG test 18 days after fertilization of the oocyte, achieved within 10 months and 2 weeks after randomization)
- Biochemical pregnancy loss (of which the biochemical pregnancy should be achieved within 10 months and 2 weeks after randomization, and of which the pregnancy has demised before ultrasound evaluation)
- Multiple pregnancy rate (of which the ongoing pregnancy should be achieved within 12 months after randomization)
- Time to pregnancy (defined as time from randomization to biochemical pregnancy leading to live birth, of which the biochemical pregnancy is achieved within 10 months and 2 weeks after randomization.)
- Costs
- Endometrial tissue parameters associated (only for nested study) with implantation failure (but not limited to, because this field is undergoing rapid innovation): endometrial gene< expression profile (“RIF array”), quality of decidualization, measurement of prolactin and of IGFBP1, determination of the steroid profile and local (intracrine) activity of steroid enzymes
- Endometrial organoids (only for nested study within the UMC Utrecht) will be cultured from the cryopreserved endometrial tissue."


Timepoints:
"12 months of FU" replaced by "12 months of follow-up after randomization"
- RECORD31-jul-2015 - 2-feb-2018


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl