The Accuracy of Endometrial Ultrasound to Predict Implantation

Completed

• Conditions: Infertility, Subfertility

• Registration Number: NCT03860636
• Lead Sponsor: University of Nottingham

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.

Study Timeline

• Study First Submitted: 2018-11-02
• Study Start: 2018-11-26
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-03-04
• Primary Completion: 2022-02-28
• Study Completion: 2022-04-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 155

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Number of ectopic pregnancies	Within 10 weeks after embryo transfer	Ectopic pregnancy resulting from the treatment cycle

Trial Locations

Locations (1)

Nurture Fertility; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom