The Accuracy of Endometrial Ultrasound to Predict Implantation

NCT ID: NCT03860636

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-26

Study Completion Date

2022-04-13

Brief Summary

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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

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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

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Infertility, Subfertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fresh Embryo Transfer

Women will be invited to attend and have transvaginal ultrasound scans (TVUS) and blood tests at three different points during their treatments.

* The day they receive their HCG trigger,
* The day of transvaginal oocyte retrieval (TVOR) and
* The day of embryo transfer (ET).

Endometrial Pattern on Ultrasound at ET

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Endometrial Pattern on Ultrasound at HCG

Intervention Type DIAGNOSTIC_TEST

Ultrasound

Endometrial Pattern on Ultrasound at TVOR

Intervention Type DIAGNOSTIC_TEST

Ultrasound

Endometrial thickness at HCG

Intervention Type DIAGNOSTIC_TEST

Ultrasound

Endometrial thickness at TVOR

Intervention Type DIAGNOSTIC_TEST

Ultrasound

Endometrial thickness at ET

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Endometrial volume at HCG

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Endometrial volume at TVOR

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Endometrial volume at ET

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Blood test for progesterone at HCG

Intervention Type DIAGNOSTIC_TEST

Blood test

Blood test for progesterone at TVOR

Intervention Type DIAGNOSTIC_TEST

Blood test

Blood test for progesterone at ET

Intervention Type DIAGNOSTIC_TEST

Blood test

Blood test for estradiol at HCG

Intervention Type DIAGNOSTIC_TEST

Blood test

Blood test for estradiol at TVOR

Intervention Type DIAGNOSTIC_TEST

Blood test

Blood test for estradiol at ET

Intervention Type DIAGNOSTIC_TEST

Blood test

Endometrial blood flow (doppler) at HCG

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Endometrial blood flow (doppler) at TVOR

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Endometrial blood flow (doppler) at ET

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Contractility at embryo transfer on a subgroup of participants

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Change in endometrial pattern between HCG and ET

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Frozen Embryo Transfer

Women will be invited to attend and have transvaginal ultrasound scans (TVUS) and blood tests at two different points during their treatments.

* The day we coordinate with embryologist (day of progesterone +/-1)
* The day of embryo transfer (ET).

Endometrial Pattern on Ultrasound at ET

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Endometrial Pattern on Ultrasound at co-ordination scan

Intervention Type DIAGNOSTIC_TEST

Ultrasound

Endometrial thickness at ET

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Endometrial thickness at coordination scan

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Endometrial volume at ET

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Endometrial volume at coordination scan

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Blood test for progesterone at ET

Intervention Type DIAGNOSTIC_TEST

Blood test

Blood test for progesterone at coordination scan

Intervention Type DIAGNOSTIC_TEST

Blood test

Change in endometrial pattern between TVOR and ET

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Blood test for estradiol at ET

Intervention Type DIAGNOSTIC_TEST

Blood test

Blood test for estradiol at coordination scan

Intervention Type DIAGNOSTIC_TEST

Blood test

Endometrial blood flow (doppler) at ET

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Endometrial blood flow (doppler) at coordination scan

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Contractility at embryo transfer on a subgroup of participants

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Change in endometrial pattern between coordination scan and ET

Intervention Type DIAGNOSTIC_TEST

Ultrasound scan

Interventions

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Endometrial Pattern on Ultrasound at ET

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Endometrial Pattern on Ultrasound at HCG

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Endometrial Pattern on Ultrasound at TVOR

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Endometrial Pattern on Ultrasound at co-ordination scan

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Endometrial thickness at HCG

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Endometrial thickness at TVOR

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Endometrial thickness at ET

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Endometrial thickness at coordination scan

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Endometrial volume at HCG

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Endometrial volume at TVOR

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Endometrial volume at ET

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Endometrial volume at coordination scan

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Blood test for progesterone at HCG

Blood test

Intervention Type DIAGNOSTIC_TEST

Blood test for progesterone at TVOR

Blood test

Intervention Type DIAGNOSTIC_TEST

Blood test for progesterone at ET

Blood test

Intervention Type DIAGNOSTIC_TEST

Blood test for progesterone at coordination scan

Blood test

Intervention Type DIAGNOSTIC_TEST

Change in endometrial pattern between TVOR and ET

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Blood test for estradiol at HCG

Blood test

Intervention Type DIAGNOSTIC_TEST

Blood test for estradiol at TVOR

Blood test

Intervention Type DIAGNOSTIC_TEST

Blood test for estradiol at ET

Blood test

Intervention Type DIAGNOSTIC_TEST

Blood test for estradiol at coordination scan

Blood test

Intervention Type DIAGNOSTIC_TEST

Endometrial blood flow (doppler) at HCG

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Endometrial blood flow (doppler) at TVOR

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Endometrial blood flow (doppler) at ET

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Endometrial blood flow (doppler) at coordination scan

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Contractility at embryo transfer on a subgroup of participants

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Change in endometrial pattern between coordination scan and ET

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Change in endometrial pattern between HCG and ET

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Nick Raine Fenning

Chief Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicholas Raine-Fenning, MRCOG PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham, Nurture Fertility Director

Locations

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Nurture Fertility

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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REC 87-1808

Identifier Type: -

Identifier Source: org_study_id

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