Infertility, SubfertilityNCT03860636
The Accuracy of Endometrial Ultrasound to Predict Implantation
An observational study of Infertility, Subfertility, run by University of Nottingham at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Subfertility
- What is being tested?
- Endometrial Pattern on Ultrasound at ET, Endometrial Pattern on Ultrasound at HCG and Endometrial Pattern on Ultrasound at TVOR
- How many people
- 155 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Nov 2018to 13 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who are having in vitro fertilisation or intracytoplasmic sperm injection where a clear image of endometrial pattern can be obtained. In cases where we can't obtain a clear endometrial pattern due to pathology or uterine position, we will exclude these cases from analysis. In cases of failure of fertilisation where no embryo is available for transfer these cases will be excluded from analysis.
Who may be able to join
- Female undergoing in vitro fertilisation or intracytoplasmic sperm injection (IVF/ICSI)
- Own or donated eggs
- Informed consent
Who cannot join
- Known pathology affecting the endometrial cavity (polyp, submucosal fibroid)
- Septate uterus or more complex uterine abnormality.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nurture Fertility
Nottingham, Nottinghamshire, NG10 5QG
About this study
Official title: The Prognostic Accuracy of Within Cycle, Pre-embryo Transfer, Ultrasound Endometrial Patterns, to Predict Implantation During Assisted Reproduction
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).
Read the 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
- Being tested
- Endometrial Pattern on Ultrasound at ET, Endometrial Pattern on Ultrasound at HCG, Endometrial Pattern on Ultrasound at TVOR, Endometrial Pattern on Ultrasound at co-ordination scan, Endometrial thickness at HCG
- Keywords
- In Vitro Fertilisation (IVF), Intra Cytoplasmic Injection (ICSI), Endometrial Pattern, Ultrasound
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial Pattern on Ultrasound at ETDiagnostic test
Ultrasound scan
Endometrial Pattern on Ultrasound at HCGDiagnostic test
Ultrasound
Endometrial Pattern on Ultrasound at TVORDiagnostic test
Ultrasound
Endometrial Pattern on Ultrasound at co-ordination scanDiagnostic test
Ultrasound
Endometrial thickness at HCGDiagnostic test
Ultrasound
Endometrial thickness at TVORDiagnostic test
Ultrasound
Endometrial thickness at ETDiagnostic test
Ultrasound scan
Endometrial thickness at coordination scanDiagnostic test
Ultrasound scan
Endometrial volume at HCGDiagnostic test
Ultrasound scan
Endometrial volume at TVORDiagnostic test
Ultrasound scan
Endometrial volume at ETDiagnostic test
Ultrasound scan
Endometrial volume at coordination scanDiagnostic test
Ultrasound scan
Blood test for progesterone at HCGDiagnostic test
Blood test
Blood test for progesterone at TVORDiagnostic test
Blood test
Blood test for progesterone at ETDiagnostic test
Blood test
Blood test for progesterone at coordination scanDiagnostic test
Blood test
Change in endometrial pattern between TVOR and ETDiagnostic test
Ultrasound scan
Blood test for estradiol at HCGDiagnostic test
Blood test
Blood test for estradiol at TVORDiagnostic test
Blood test
Blood test for estradiol at ETDiagnostic test
Blood test
Blood test for estradiol at coordination scanDiagnostic test
Blood test
Endometrial blood flow (doppler) at HCGDiagnostic test
Ultrasound scan
Endometrial blood flow (doppler) at TVORDiagnostic test
Ultrasound scan
Endometrial blood flow (doppler) at ETDiagnostic test
Ultrasound scan
Endometrial blood flow (doppler) at coordination scanDiagnostic test
Ultrasound scan
Contractility at embryo transfer on a subgroup of participantsDiagnostic test
Ultrasound scan
Change in endometrial pattern between coordination scan and ETDiagnostic test
Ultrasound scan
Change in endometrial pattern between HCG and ETDiagnostic test
Ultrasound scan
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Endometrial Pattern on Ultrasound at ET; Diagnostic Test: Endometrial Pattern on Ultrasound at HCG; Diagnostic Test: Endometrial Pattern on Ultrasound at TVOR; Diagnostic Test: Endometrial thickness at HCG; Diagnostic Test: Endometrial thickness at TVOR; Diagnostic Test: Endometrial thickness at ET; Diagnostic Test: Endometrial volume at HCG; Diagnostic Test: Endometrial volume at TVOR; Diagnostic Test: Endometrial volume at ET; Diagnostic Test: Blood test for progesterone at HCG; Diagnostic Test: Blood test for progesterone at TVOR; Diagnostic Test: Blood test for progesterone at ET; Diagnostic Test: Blood test for estradiol at HCG; Diagnostic Test: Blood test for estradiol at TVOR; Diagnostic Test: Blood test for estradiol at ET; Diagnostic Test: Endometrial blood flow (doppler) at HCG; Diagnostic Test: Endometrial blood flow (doppler) at TVOR; Diagnostic Test: Endometrial blood flow (doppler) at ET; Diagnostic Test: Contractility at embryo transfer on a subgroup of participants; Diagnostic Test: Change in endometrial pattern between HCG and ET | |
| 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). Receives: Diagnostic Test: Endometrial Pattern on Ultrasound at ET; Diagnostic Test: Endometrial Pattern on Ultrasound at co-ordination scan; Diagnostic Test: Endometrial thickness at ET; Diagnostic Test: Endometrial thickness at coordination scan; Diagnostic Test: Endometrial volume at ET; Diagnostic Test: Endometrial volume at coordination scan; Diagnostic Test: Blood test for progesterone at ET; Diagnostic Test: Blood test for progesterone at coordination scan; Diagnostic Test: Change in endometrial pattern between TVOR and ET; Diagnostic Test: Blood test for estradiol at ET; Diagnostic Test: Blood test for estradiol at coordination scan; Diagnostic Test: Endometrial blood flow (doppler) at ET; Diagnostic Test: Endometrial blood flow (doppler) at coordination scan; Diagnostic Test: Contractility at embryo transfer on a subgroup of participants; Diagnostic Test: Change in endometrial pattern between coordination scan and ET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of clinical pregnancies
Intrauterine pregnancy with fetal heart detected on ultrasound arising from the treatment cycle
Measured: Within 12 weeks after embryo transfer (usually scan performed at 6-7 weeks gestation)
Secondary outcomes (4)
Number of ectopic pregnancies
Ectopic pregnancy resulting from the treatment cycle
Measured: Within 10 weeks after embryo transfer
Number of biochemical pregnancies
Biochemical pregnancy resulting from the treatment cycle
Measured: Within 6 weeks after embryo tranfer
Number of miscarriages
Miscarriage resulting from the treatment cycle
Measured: Within 12 weeks after embryo transfer
Number of live birth
Live birth resulting from the treatment cycle
Measured: Within one year after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start26 Nov 2018
- Primary completion28 Feb 2022
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, SubfertilityStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nick Raine Fenning, University of Nottingham
- Investigators
- Nicholas Raine-Fenning, MRCOG PhD, Principal investigator, University of Nottingham, Nurture Fertility Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860636
- Sponsor's protocol ID
- REC 87-1808
- Status last verified
- Mar 2025
- First submitted
- 2 Nov 2018
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Accuracy of Within Cycle, Pre-embryo Transfer, Ultrasound Endometrial Patterns, to Predict Implantation During Assisted Reproduction
- ClinicalTrials.gov ID
- NCT03860636
- Acronym / sponsor ID
- REC 87-1808
- Conditions
- Infertility, Subfertility
- Keywords
- In Vitro Fertilisation (IVF), Intra Cytoplasmic Injection (ICSI), Endometrial Pattern, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh Embryo Transfer | – | Diagnostic Test: Endometrial Pattern on Ultrasound at ET, Diagnostic Test: Endometrial Pattern on Ultrasound at HCG, Diagnostic Test: Endometrial Pattern on Ultrasound at TVOR, Diagnostic Test: Endometrial thickness at HCG, Diagnostic Test: Endometrial thickness at TVOR, Diagnostic Test: Endometrial thickness at ET, Diagnostic Test: Endometrial volume at HCG, Diagnostic Test: Endometrial volume at TVOR, Diagnostic Test: Endometrial volume at ET, Diagnostic Test: Blood test for progesterone at HCG, Diagnostic Test: Blood test for progesterone at TVOR, Diagnostic Test: Blood test for progesterone at ET, Diagnostic Test: Blood test for estradiol at HCG, Diagnostic Test: Blood test for estradiol at TVOR, Diagnostic Test: Blood test for estradiol at ET, Diagnostic Test: Endometrial blood flow (doppler) at HCG, Diagnostic Test: Endometrial blood flow (doppler) at TVOR, Diagnostic Test: Endometrial blood flow (doppler) at ET, Diagnostic Test: Contractility at embryo transfer on a subgroup of participants, Diagnostic Test: Change in endometrial pattern between HCG and ETWomen 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). |
| Frozen Embryo Transfer | – | Diagnostic Test: Endometrial Pattern on Ultrasound at ET, Diagnostic Test: Endometrial Pattern on Ultrasound at co-ordination scan, Diagnostic Test: Endometrial thickness at ET, Diagnostic Test: Endometrial thickness at coordination scan, Diagnostic Test: Endometrial volume at ET, Diagnostic Test: Endometrial volume at coordination scan, Diagnostic Test: Blood test for progesterone at ET, Diagnostic Test: Blood test for progesterone at coordination scan, Diagnostic Test: Change in endometrial pattern between TVOR and ET, Diagnostic Test: Blood test for estradiol at ET, Diagnostic Test: Blood test for estradiol at coordination scan, Diagnostic Test: Endometrial blood flow (doppler) at ET, Diagnostic Test: Endometrial blood flow (doppler) at coordination scan, Diagnostic Test: Contractility at embryo transfer on a subgroup of participants, Diagnostic Test: Change in endometrial pattern between coordination scan and ETWomen 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who are having in vitro fertilisation or intracytoplasmic sperm injection where a clear image of endometrial pattern can be obtained. In cases where we can't obtain a clear endometrial pattern due to pathology or uterine position, we will exclude these cases from analysis. In cases of failure of fertilisation where no embryo is available for transfer these cases will be excluded from analysis.
Key inclusion criteria (3 listed)
- Female undergoing in vitro fertilisation or intracytoplasmic sperm injection (IVF/ICSI)
- Own or donated eggs
- Informed consent
Key exclusion criteria (2 listed)
- Known pathology affecting the endometrial cavity (polyp, submucosal fibroid)
- Septate uterus or more complex uterine abnormality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial Pattern on Ultrasound at ETUltrasound scan | Diagnostic test | Fresh Embryo Transfer, Frozen Embryo Transfer |
| Endometrial Pattern on Ultrasound at HCGUltrasound | Diagnostic test | Fresh Embryo Transfer |
| Endometrial Pattern on Ultrasound at TVORUltrasound | Diagnostic test | Fresh Embryo Transfer |
| Endometrial Pattern on Ultrasound at co-ordination scanUltrasound | Diagnostic test | Frozen Embryo Transfer |
| Endometrial thickness at HCGUltrasound | Diagnostic test | Fresh Embryo Transfer |
| Endometrial thickness at TVORUltrasound | Diagnostic test | Fresh Embryo Transfer |
| Endometrial thickness at ETUltrasound scan | Diagnostic test | Fresh Embryo Transfer, Frozen Embryo Transfer |
| Endometrial thickness at coordination scanUltrasound scan | Diagnostic test | Frozen Embryo Transfer |
| Endometrial volume at HCGUltrasound scan | Diagnostic test | Fresh Embryo Transfer |
| Endometrial volume at TVORUltrasound scan | Diagnostic test | Fresh Embryo Transfer |
| Endometrial volume at ETUltrasound scan | Diagnostic test | Fresh Embryo Transfer, Frozen Embryo Transfer |
| Endometrial volume at coordination scanUltrasound scan | Diagnostic test | Frozen Embryo Transfer |
| Blood test for progesterone at HCGBlood test | Diagnostic test | Fresh Embryo Transfer |
| Blood test for progesterone at TVORBlood test | Diagnostic test | Fresh Embryo Transfer |
| Blood test for progesterone at ETBlood test | Diagnostic test | Fresh Embryo Transfer, Frozen Embryo Transfer |
| Blood test for progesterone at coordination scanBlood test | Diagnostic test | Frozen Embryo Transfer |
| Change in endometrial pattern between TVOR and ETUltrasound scan | Diagnostic test | Frozen Embryo Transfer |
| Blood test for estradiol at HCGBlood test | Diagnostic test | Fresh Embryo Transfer |
| Blood test for estradiol at TVORBlood test | Diagnostic test | Fresh Embryo Transfer |
| Blood test for estradiol at ETBlood test | Diagnostic test | Fresh Embryo Transfer, Frozen Embryo Transfer |
| Blood test for estradiol at coordination scanBlood test | Diagnostic test | Frozen Embryo Transfer |
| Endometrial blood flow (doppler) at HCGUltrasound scan | Diagnostic test | Fresh Embryo Transfer |
| Endometrial blood flow (doppler) at TVORUltrasound scan | Diagnostic test | Fresh Embryo Transfer |
| Endometrial blood flow (doppler) at ETUltrasound scan | Diagnostic test | Fresh Embryo Transfer, Frozen Embryo Transfer |
| Endometrial blood flow (doppler) at coordination scanUltrasound scan | Diagnostic test | Frozen Embryo Transfer |
| Contractility at embryo transfer on a subgroup of participantsUltrasound scan | Diagnostic test | Fresh Embryo Transfer, Frozen Embryo Transfer |
| Change in endometrial pattern between coordination scan and ETUltrasound scan | Diagnostic test | Frozen Embryo Transfer |
| Change in endometrial pattern between HCG and ETUltrasound scan | Diagnostic test | Fresh Embryo Transfer |
Primary outcome
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
4 secondary outcomes
Number of ectopic pregnancies
Time frame: Within 10 weeks after embryo transfer
Number of biochemical pregnancies
Time frame: Within 6 weeks after embryo tranfer
Number of miscarriages
Time frame: Within 12 weeks after embryo transfer
Number of live birth
Time frame: Within one year after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Raine-Fenning, MRCOG PhD principal investigator
University of Nottingham, Nurture Fertility Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Subfertility, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of clinical pregnancies (time frame: Within 12 weeks after embryo transfer (usually scan performed at 6-7 weeks gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.