The Accuracy of Endometrial Ultrasound to Predict Implantation
NCT ID: NCT03860636
Last Updated: 2025-04-02
Study Results
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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COMPLETED
155 participants
OBSERVATIONAL
2018-11-26
2022-04-13
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
Ultrasound scan
Endometrial Pattern on Ultrasound at HCG
Ultrasound
Endometrial Pattern on Ultrasound at TVOR
Ultrasound
Endometrial thickness at HCG
Ultrasound
Endometrial thickness at TVOR
Ultrasound
Endometrial thickness at ET
Ultrasound scan
Endometrial volume at HCG
Ultrasound scan
Endometrial volume at TVOR
Ultrasound scan
Endometrial volume at ET
Ultrasound scan
Blood test for progesterone at HCG
Blood test
Blood test for progesterone at TVOR
Blood test
Blood test for progesterone at ET
Blood test
Blood test for estradiol at HCG
Blood test
Blood test for estradiol at TVOR
Blood test
Blood test for estradiol at ET
Blood test
Endometrial blood flow (doppler) at HCG
Ultrasound scan
Endometrial blood flow (doppler) at TVOR
Ultrasound scan
Endometrial blood flow (doppler) at ET
Ultrasound scan
Contractility at embryo transfer on a subgroup of participants
Ultrasound scan
Change in endometrial pattern between HCG and ET
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
Ultrasound scan
Endometrial Pattern on Ultrasound at co-ordination scan
Ultrasound
Endometrial thickness at ET
Ultrasound scan
Endometrial thickness at coordination scan
Ultrasound scan
Endometrial volume at ET
Ultrasound scan
Endometrial volume at coordination scan
Ultrasound scan
Blood test for progesterone at ET
Blood test
Blood test for progesterone at coordination scan
Blood test
Change in endometrial pattern between TVOR and ET
Ultrasound scan
Blood test for estradiol at ET
Blood test
Blood test for estradiol at coordination scan
Blood test
Endometrial blood flow (doppler) at ET
Ultrasound scan
Endometrial blood flow (doppler) at coordination scan
Ultrasound scan
Contractility at embryo transfer on a subgroup of participants
Ultrasound scan
Change in endometrial pattern between coordination scan and ET
Ultrasound scan
Interventions
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Endometrial Pattern on Ultrasound at ET
Ultrasound scan
Endometrial Pattern on Ultrasound at HCG
Ultrasound
Endometrial Pattern on Ultrasound at TVOR
Ultrasound
Endometrial Pattern on Ultrasound at co-ordination scan
Ultrasound
Endometrial thickness at HCG
Ultrasound
Endometrial thickness at TVOR
Ultrasound
Endometrial thickness at ET
Ultrasound scan
Endometrial thickness at coordination scan
Ultrasound scan
Endometrial volume at HCG
Ultrasound scan
Endometrial volume at TVOR
Ultrasound scan
Endometrial volume at ET
Ultrasound scan
Endometrial volume at coordination scan
Ultrasound scan
Blood test for progesterone at HCG
Blood test
Blood test for progesterone at TVOR
Blood test
Blood test for progesterone at ET
Blood test
Blood test for progesterone at coordination scan
Blood test
Change in endometrial pattern between TVOR and ET
Ultrasound scan
Blood test for estradiol at HCG
Blood test
Blood test for estradiol at TVOR
Blood test
Blood test for estradiol at ET
Blood test
Blood test for estradiol at coordination scan
Blood test
Endometrial blood flow (doppler) at HCG
Ultrasound scan
Endometrial blood flow (doppler) at TVOR
Ultrasound scan
Endometrial blood flow (doppler) at ET
Ultrasound scan
Endometrial blood flow (doppler) at coordination scan
Ultrasound scan
Contractility at embryo transfer on a subgroup of participants
Ultrasound scan
Change in endometrial pattern between coordination scan and ET
Ultrasound scan
Change in endometrial pattern between HCG and ET
Ultrasound scan
Eligibility Criteria
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Inclusion Criteria
* Own or donated eggs
* Informed consent
Exclusion Criteria
* Septate uterus or more complex uterine abnormality.
18 Years
FEMALE
Yes
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Nick Raine Fenning
Chief 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
Countries
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Other Identifiers
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REC 87-1808
Identifier Type: -
Identifier Source: org_study_id
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