The Prognostic Accuracy of Within Cycle, Pre-embryo Transfer, Ultrasound Endometrial Patterns, to Predict Implantation During Assisted Reproduction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility, Subfertility
- Sponsor
- University of Nottingham
- Enrollment
- 155
- Locations
- 1
- Primary Endpoint
- Number of clinical pregnancies
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Nick Raine Fenning
Chief Investigator
University of Nottingham
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Number of clinical pregnancies
Time Frame: 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 Outcomes
- Number of biochemical pregnancies(Within 6 weeks after embryo tranfer)
- Number of miscarriages(Within 12 weeks after embryo transfer)
- Number of live birth(Within one year after embryo transfer)
- Number of ectopic pregnancies(Within 10 weeks after embryo transfer)