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OpenTrials
Completed

NCT Number: NCT03860636

The Accuracy of Endometrial Ultrasound to Predict Implantation

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Nurture Fertility

Nottingham, Nottinghamshire, NG10 5QG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endometrial Pattern on Ultrasound at ET

Diagnostic Test

Ultrasound scan

Endometrial Pattern on Ultrasound at HCG

Diagnostic Test

Ultrasound

Endometrial Pattern on Ultrasound at TVOR

Diagnostic Test

Ultrasound

Endometrial Pattern on Ultrasound at co-ordination scan

Diagnostic Test

Ultrasound

Endometrial thickness at HCG

Diagnostic Test

Ultrasound

Endometrial thickness at TVOR

Diagnostic Test

Ultrasound

Endometrial thickness at ET

Diagnostic Test

Ultrasound scan

Endometrial thickness at coordination scan

Diagnostic Test

Ultrasound scan

Endometrial volume at HCG

Diagnostic Test

Ultrasound scan

Endometrial volume at TVOR

Diagnostic Test

Ultrasound scan

Endometrial volume at ET

Diagnostic Test

Ultrasound scan

Endometrial volume at coordination scan

Diagnostic Test

Ultrasound scan

Blood test for progesterone at HCG

Diagnostic Test

Blood test

Blood test for progesterone at TVOR

Diagnostic Test

Blood test

Blood test for progesterone at ET

Diagnostic Test

Blood test

Blood test for progesterone at coordination scan

Diagnostic Test

Blood test

Change in endometrial pattern between TVOR and ET

Diagnostic Test

Ultrasound scan

Blood test for estradiol at HCG

Diagnostic Test

Blood test

Blood test for estradiol at TVOR

Diagnostic Test

Blood test

Blood test for estradiol at ET

Diagnostic Test

Blood test

Blood test for estradiol at coordination scan

Diagnostic Test

Blood test

Endometrial blood flow (doppler) at HCG

Diagnostic Test

Ultrasound scan

Endometrial blood flow (doppler) at TVOR

Diagnostic Test

Ultrasound scan

Endometrial blood flow (doppler) at ET

Diagnostic Test

Ultrasound scan

Endometrial blood flow (doppler) at coordination scan

Diagnostic Test

Ultrasound scan

Contractility at embryo transfer on a subgroup of participants

Diagnostic Test

Ultrasound scan

Change in endometrial pattern between coordination scan and ET

Diagnostic Test

Ultrasound scan

Change in endometrial pattern between HCG and ET

Diagnostic Test

Ultrasound scan

Primary outcomes

  1. 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

  1. Number of ectopic pregnancies

    Time frame: Within 10 weeks after embryo transfer

    Ectopic pregnancy resulting from the treatment cycle

  2. Number of biochemical pregnancies

    Time frame: Within 6 weeks after embryo tranfer

    Biochemical pregnancy resulting from the treatment cycle

  3. Number of miscarriages

    Time frame: Within 12 weeks after embryo transfer

    Miscarriage resulting from the treatment cycle

  4. Number of live birth

    Time frame: Within one year after embryo transfer

    Live birth resulting from the treatment cycle

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2019
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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