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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
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| |
| 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endometrial Pattern on Ultrasound at ET | Diagnostic Test | Ultrasound scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of clinical pregnancies | Intrauterine pregnancy with fetal heart detected on ultrasound arising from the treatment cycle | Within 12 weeks after embryo transfer (usually scan performed at 6-7 weeks gestation) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ectopic pregnancies | Ectopic pregnancy resulting from the treatment cycle | Within 10 weeks after embryo transfer |
| Number of biochemical pregnancies | Biochemical pregnancy resulting from the treatment cycle |
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Inclusion Criteria:
Exclusion Criteria:
Female
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Raine-Fenning, MRCOG PhD | University of Nottingham, Nurture Fertility Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nurture Fertility | Nottingham | Nottinghamshire | NG10 5QG | United Kingdom |
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Blood for progesterone and estradiol
| 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 |
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| Endometrial blood flow (doppler) at TVOR | Diagnostic Test | Ultrasound scan |
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| 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 |
|
| Within 6 weeks after embryo tranfer |
| Number of miscarriages | Miscarriage resulting from the treatment cycle | Within 12 weeks after embryo transfer |
| Number of live birth | Live birth resulting from the treatment cycle | Within one year after embryo transfer |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| D015150 | Echocardiography, Doppler |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D004452 | Echocardiography |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
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