NCT03860636

The Accuracy of Endometrial Ultrasound to Predict Implantation

The Prognostic Accuracy of Within Cycle, Pre-embryo Transfer, Ultrasound Endometrial Patterns, to Predict Implantation During Assisted Reproduction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 155 (actual)
• Sponsor: University of Nottingham · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infertility, Subfertility

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Endometrial Pattern on Ultrasound at ET	Ultrasound scan
DIAGNOSTIC_TEST	Endometrial Pattern on Ultrasound at HCG	Ultrasound
DIAGNOSTIC_TEST	Endometrial Pattern on Ultrasound at TVOR	Ultrasound
DIAGNOSTIC_TEST	Endometrial Pattern on Ultrasound at co-ordination scan	Ultrasound
DIAGNOSTIC_TEST	Endometrial thickness at HCG	Ultrasound
DIAGNOSTIC_TEST	Endometrial thickness at TVOR	Ultrasound
DIAGNOSTIC_TEST	Endometrial thickness at ET	Ultrasound scan
DIAGNOSTIC_TEST	Endometrial thickness at coordination scan	Ultrasound scan
DIAGNOSTIC_TEST	Endometrial volume at HCG	Ultrasound scan
DIAGNOSTIC_TEST	Endometrial volume at TVOR	Ultrasound scan
DIAGNOSTIC_TEST	Endometrial volume at ET	Ultrasound scan
DIAGNOSTIC_TEST	Endometrial volume at coordination scan	Ultrasound scan
DIAGNOSTIC_TEST	Blood test for progesterone at HCG	Blood test
DIAGNOSTIC_TEST	Blood test for progesterone at TVOR	Blood test
DIAGNOSTIC_TEST	Blood test for progesterone at ET	Blood test
DIAGNOSTIC_TEST	Blood test for progesterone at coordination scan	Blood test
DIAGNOSTIC_TEST	Change in endometrial pattern between TVOR and ET	Ultrasound scan
DIAGNOSTIC_TEST	Blood test for estradiol at HCG	Blood test
DIAGNOSTIC_TEST	Blood test for estradiol at TVOR	Blood test
DIAGNOSTIC_TEST	Blood test for estradiol at ET	Blood test
DIAGNOSTIC_TEST	Blood test for estradiol at coordination scan	Blood test
DIAGNOSTIC_TEST	Endometrial blood flow (doppler) at HCG	Ultrasound scan
DIAGNOSTIC_TEST	Endometrial blood flow (doppler) at TVOR	Ultrasound scan
DIAGNOSTIC_TEST	Endometrial blood flow (doppler) at ET	Ultrasound scan
DIAGNOSTIC_TEST	Endometrial blood flow (doppler) at coordination scan	Ultrasound scan
DIAGNOSTIC_TEST	Contractility at embryo transfer on a subgroup of participants	Ultrasound scan
DIAGNOSTIC_TEST	Change in endometrial pattern between coordination scan and ET	Ultrasound scan
DIAGNOSTIC_TEST	Change in endometrial pattern between HCG and ET	Ultrasound scan

Timeline

• Start date: 2018-11-26
• Primary completion: 2022-02-28
• Completion: 2022-04-13
• First posted: 2019-03-04
• Last updated: 2025-04-02

Locations

1 site across 1 country: United Kingdom