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…
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing pregnancy leading to live birth after the second fresh IVF/ICSI cycle.
Secondary outcome
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, endometrial
tissue parameters associated with implantation failure.
Background summary
Despite numerous developments in the field of assisted reproductive technology
the maximum chance of implantation per transferred embryo is still only 30%.
This means failure of implantation occurs in a staggering 70% of embryos. This
*black box of embryo loss* is by far the biggest challenge in modern day IVF.
Failure of implantation does not only cause a considerable psychological and
physical burden for the patient, but also causes considerable costs due to
repeated IVF/ICSI cycles.
Based on the literature, an increase of clinical pregnancy and live birth rates
after endometrial scratching in novice ART as well as after implantation
failure is most likely. In view of the considerable level of heterogeneity, a
large RCT should clarify the extent of the positive effect in implantation
failure and erase the statistical heterogeneity of the presently available
RCTs. In addition, for the purpose of implementation of endometrial scratching,
a cost-effectiveness analysis should be performed.
Study 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) leads to a
higher number of ongoing pregnancies leading to live birth after the second
fresh ART cycle as compared to no scratching.
Study design
National, multicentre (academic and non-academic) randomized, non-blinded,
controlled trial with a cost-effectiveness analysis
Intervention
SCRaTCH: Endometrial scratch before starting a second IVF/ICSI cycle
Control: no scratch but direct start of 2nd IVF/ICSI cycle
Study burden and risks
Patients who are randomized for endometrial scratching will pay one extra visit
to the hospital. From existing literature it is clear that the rate of adverse
events is very low. Pain based on uterine contractions and a small amount of
bleeding is noted during the procedure in most participants. However, no woman
complained of bleeding or pain in the days following the procedure. No
complications such as uterine or pelvic infections have been reported so far in
a total of 650 procedures reported in prospective RCTs. The benefit is an, as
of yet, unknown increase in the chance to conceive in patients starting their
second IVF/ICSI treatment.
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
1. Female age 18-43 years
2. Implantation failure (IF) defined as the absence of a clinical 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 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. 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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT5342 |
| CCMO | NL54552.041.15 |
| OMON | NL-OMON26706 |