Infertility, Subfertility
Conditions
Keywords
In Vitro Fertilisation (IVF), Intra Cytoplasmic Injection (ICSI), Endometrial Pattern, Ultrasound
Brief summary
To measure the accuracy of different ultrasound endometrial patterns to predict successful embryo implantation during assisted conception; in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).
Detailed description
Ultrasound appearance of the endometrium may predict successful implantation in assisted conception, but studies have yielded conflicting results. The explanation may be different timing of, and classification systems for, the scan, different treatment protocols, and different definitions of success. Also scan quality has improved over time. This is a prospective study looking at the endometrial pattern as a predictor of IVF/ICSI outcome, adjusting for embryo quality, ease of transfer, and fresh or frozen cycles. The study will focus on good quality single embryo transfer at the blastocyst stage. Other endometrial ultrasound parameters such as thickness, volume and Doppler will also be measured. Reliability studies will also be conducted to assess and account for inter- and intra-observer variation. 200 women will be recruited. They will include approximately 100 undergoing fresh and 100 undergoing frozen embryo transfer. There will be no change to routine clinical care. A single operator will analyse all ultrasound images to reduce inter-observer variation. When there is uncertainty about the pattern the chief investigator will be consulted to reach an agreement.
Interventions
Ultrasound scan
Ultrasound
Ultrasound
Ultrasound
Ultrasound
Ultrasound
Ultrasound scan
Ultrasound scan
Ultrasound scan
Ultrasound scan
Ultrasound scan
Ultrasound scan
Blood test
Blood test
Blood test
Blood test
Ultrasound scan
Blood test
Blood test
Blood test
Blood test
Ultrasound scan
Ultrasound scan
Ultrasound scan
Ultrasound scan
Ultrasound scan
Ultrasound scan
Ultrasound scan
Sponsors
Study design
Eligibility
Inclusion criteria
* Female undergoing in vitro fertilisation or intracytoplasmic sperm injection (IVF/ICSI) * Own or donated eggs * Informed consent
Exclusion criteria
* Known pathology affecting the endometrial cavity (polyp, submucosal fibroid) * Septate uterus or more complex uterine abnormality.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of clinical pregnancies | Within 12 weeks after embryo transfer (usually scan performed at 6-7 weeks gestation) | Intrauterine pregnancy with fetal heart detected on ultrasound arising from the treatment cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of ectopic pregnancies | Within 10 weeks after embryo transfer | Ectopic pregnancy resulting from the treatment cycle |
| Number of biochemical pregnancies | Within 6 weeks after embryo tranfer | Biochemical pregnancy resulting from the treatment cycle |
| Number of miscarriages | Within 12 weeks after embryo transfer | Miscarriage resulting from the treatment cycle |
| Number of live birth | Within one year after embryo transfer | Live birth resulting from the treatment cycle |
Countries
United Kingdom