Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicine
Conditions
Interventions
Women will be randomised to either the intervention or control arm using an online system at a ratio of 1:1 using stratified block randomisation with variable blinded block sizes. Intervention partici
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged = 18 and = 37 years of age at time of oocyte removal 2. Women expected to receive IVF with or without ICSI treatment using the antagonist or long protocol only 3. First time IVF with or without ICSI treatment 4. Ovulatory menstrual cycle. (Regular menstrual cycles with ovulatory levels of midluteal serum progesterone as defined by local laboratory protocols) 5. Normal uterine cavity assessed by transvaginal sonography at screening and no endometrial abnormalities such as , polyps, suspected intrauterine adhesions, uterine septa, submucosal fibroids or intramural fibroids exceeding 4 cm in diameter as assessed by the investigator that would require treatment to facilitate pregnancy 6. Local procedures have been followed to exclude relevant vaginal/uterine infections prior to starting treatment 7. Expected good ovarian reserve as assessed clinically and or laboratory (normal early follicular FSH (<10) & normal AMH) and no history of previous radiotherapy or chemotherapy 8. Expected good responders in whom blastocyst transfer is expected (as assessed by clinical judgement) 9. Understands/willing to comply with the protocol 10. Willing to use a condom if randomised to Endometrial Scratch (ES) in the cycle where the ES procedure is performed
Exclusion criteria
Exclusion criteria: 1. Single embryo transfer is not anticipated 2. Previous trauma/surgery to the endometrium e.g. resection of submucous fibroid, intrauterine adhesions 3. BMI= 35 kg/m2 4. Known Grade 4 (severe) endometriosis 5. Women who have received cycle programming through the use of progestogens or the contraceptive pill in the lead up to their IVF treatment and for whom a wash out period of one month will not be possible 6. Currently participating in any other fertility study or a study involving medical/surgical intervention or previously randomised into this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate (LBR) after completed 24 weeks gestation is determined by telephone contact with the participant 10.5 months post egg collection. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acceptability of the Endometrial Scratch procedure is determined by telephone contact with the participant directly after, 24 hours and 7 days post procedure 2. Implantation rate based on a positive serum Beta hCG approximately day 14 post egg collection 3. Clinical pregnancy rate is measured at/after 8 weeks gestation 4. Miscarriage rate is measured 3 and 6 month post egg collection 5. Ectopic pregnancy rate is measured at/after 8 weeks gestation 6. Multiple birth rate is measured 10.5 months post egg collection 7. Preterm delivery rate is measured 6 and 10.5 months post egg collection 8. Still birth rate is measured 6 and 10.5 months post egg collection 9. Adverse events are measured post intervention, 2 weeks, 3- 6- and 10.5 months post egg collection 10. Resource use is measured at baseline, 3 and 10.5 months post egg collection 11. Patient costs are measured 3 months post egg collection | — |
Countries
England, United Kingdom
Contacts
Public ContactRobin Chatters
Outcome results
None listed