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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03860636
Enrollment
155
Registered
2019-03-04
Start date
2018-11-26
Completion date
2022-04-13
Last updated
2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Subfertility

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

DIAGNOSTIC_TESTEndometrial Pattern on Ultrasound at ET

Ultrasound scan

DIAGNOSTIC_TESTEndometrial Pattern on Ultrasound at HCG

Ultrasound

DIAGNOSTIC_TESTEndometrial Pattern on Ultrasound at TVOR

Ultrasound

DIAGNOSTIC_TESTEndometrial Pattern on Ultrasound at co-ordination scan

Ultrasound

DIAGNOSTIC_TESTEndometrial thickness at HCG

Ultrasound

DIAGNOSTIC_TESTEndometrial thickness at TVOR

Ultrasound

DIAGNOSTIC_TESTEndometrial thickness at ET

Ultrasound scan

DIAGNOSTIC_TESTEndometrial thickness at coordination scan

Ultrasound scan

DIAGNOSTIC_TESTEndometrial volume at HCG

Ultrasound scan

DIAGNOSTIC_TESTEndometrial volume at TVOR

Ultrasound scan

DIAGNOSTIC_TESTEndometrial volume at ET

Ultrasound scan

DIAGNOSTIC_TESTEndometrial volume at coordination scan

Ultrasound scan

DIAGNOSTIC_TESTBlood test for progesterone at HCG

Blood test

DIAGNOSTIC_TESTBlood test for progesterone at TVOR

Blood test

DIAGNOSTIC_TESTBlood test for progesterone at ET

Blood test

DIAGNOSTIC_TESTBlood test for progesterone at coordination scan

Blood test

DIAGNOSTIC_TESTChange in endometrial pattern between TVOR and ET

Ultrasound scan

DIAGNOSTIC_TESTBlood test for estradiol at HCG

Blood test

DIAGNOSTIC_TESTBlood test for estradiol at TVOR

Blood test

DIAGNOSTIC_TESTBlood test for estradiol at ET

Blood test

DIAGNOSTIC_TESTBlood test for estradiol at coordination scan

Blood test

DIAGNOSTIC_TESTEndometrial blood flow (doppler) at HCG

Ultrasound scan

DIAGNOSTIC_TESTEndometrial blood flow (doppler) at TVOR

Ultrasound scan

DIAGNOSTIC_TESTEndometrial blood flow (doppler) at ET

Ultrasound scan

DIAGNOSTIC_TESTEndometrial blood flow (doppler) at coordination scan

Ultrasound scan

DIAGNOSTIC_TESTContractility at embryo transfer on a subgroup of participants

Ultrasound scan

DIAGNOSTIC_TESTChange in endometrial pattern between coordination scan and ET

Ultrasound scan

DIAGNOSTIC_TESTChange in endometrial pattern between HCG and ET

Ultrasound scan

Sponsors

University of Nottingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Number of clinical pregnanciesWithin 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

MeasureTime frameDescription
Number of ectopic pregnanciesWithin 10 weeks after embryo transferEctopic pregnancy resulting from the treatment cycle
Number of biochemical pregnanciesWithin 6 weeks after embryo tranferBiochemical pregnancy resulting from the treatment cycle
Number of miscarriagesWithin 12 weeks after embryo transferMiscarriage resulting from the treatment cycle
Number of live birthWithin one year after embryo transferLive birth resulting from the treatment cycle

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026