infertility subfertility IVF ICSI endometrial scratching endometrial injury
Conditions
Interventions
Endometrial scratch in the luteal phase of the cycle preceding the 2nd IVF/ICSI cycle
Sponsors
UMC Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: 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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - 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): endomet | — |
Contacts
Public ContactHelen Torrance
Heidelberglaan 100
Outcome results
None listed