The Accuracy of Endometrial Ultrasound to Predict Implantation

Study Overview
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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.

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

Conditions
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Infertility, Subfertility

Intervention / Treatment
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* 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 Pattern on Ultrasound at co-ordination scan
* Diagnostic Test: Endometrial thickness at HCG
* Diagnostic Test: Endometrial thickness at TVOR
* Diagnostic Test: Endometrial thickness at ET
* Diagnostic Test: Endometrial thickness at coordination scan
* Diagnostic Test: Endometrial volume at HCG
* Diagnostic Test: Endometrial volume at TVOR
* Diagnostic Test: Endometrial volume at ET
* Diagnostic Test: Endometrial volume at coordination scan
* 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 progesterone at coordination scan
* Diagnostic Test: Change in endometrial pattern between TVOR and 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: Blood test for estradiol at coordination scan
* 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: 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
* Diagnostic Test: Change in endometrial pattern between HCG and ET


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fresh Embryo Transfer<br>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). | Diagnostic Test: Endometrial Pattern on Ultrasound at ET<br>* Ultrasound scan<br>Diagnostic Test: Endometrial Pattern on Ultrasound at HCG<br>* Ultrasound<br>Diagnostic Test: Endometrial Pattern on Ultrasound at TVOR<br>* Ultrasound<br>Diagnostic Test: Endometrial thickness at HCG<br>* Ultrasound<br>Diagnostic Test: Endometrial thickness at TVOR<br>* Ultrasound<br>Diagnostic Test: Endometrial thickness at ET<br>* Ultrasound scan<br>Diagnostic Test: Endometrial volume at HCG<br>* Ultrasound scan<br>Diagnostic Test: Endometrial volume at TVOR<br>* Ultrasound scan<br>Diagnostic Test: Endometrial volume at ET<br>* Ultrasound scan<br>Diagnostic Test: Blood test for progesterone at HCG<br>* Blood test<br>Diagnostic Test: Blood test for progesterone at TVOR<br>* Blood test<br>Diagnostic Test: Blood test for progesterone at ET<br>* Blood test<br>Diagnostic Test: Blood test for estradiol at HCG<br>* Blood test<br>Diagnostic Test: Blood test for estradiol at TVOR<br>* Blood test<br>Diagnostic Test: Blood test for estradiol at ET<br>* Blood test<br>Diagnostic Test: Endometrial blood flow (doppler) at HCG<br>* Ultrasound scan<br>Diagnostic Test: Endometrial blood flow (doppler) at TVOR<br>* Ultrasound scan<br>Diagnostic Test: Endometrial blood flow (doppler) at ET<br>* Ultrasound scan<br>Diagnostic Test: Contractility at embryo transfer on a subgroup of participants<br>* Ultrasound scan<br>Diagnostic Test: Change in endometrial pattern between HCG and ET<br>* Ultrasound scan<br>|
| Frozen Embryo Transfer<br>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). | Diagnostic Test: Endometrial Pattern on Ultrasound at ET<br>* Ultrasound scan<br>Diagnostic Test: Endometrial Pattern on Ultrasound at co-ordination scan<br>* Ultrasound<br>Diagnostic Test: Endometrial thickness at ET<br>* Ultrasound scan<br>Diagnostic Test: Endometrial thickness at coordination scan<br>* Ultrasound scan<br>Diagnostic Test: Endometrial volume at ET<br>* Ultrasound scan<br>Diagnostic Test: Endometrial volume at coordination scan<br>* Ultrasound scan<br>Diagnostic Test: Blood test for progesterone at ET<br>* Blood test<br>Diagnostic Test: Blood test for progesterone at coordination scan<br>* Blood test<br>Diagnostic Test: Change in endometrial pattern between TVOR and ET<br>* Ultrasound scan<br>Diagnostic Test: Blood test for estradiol at ET<br>* Blood test<br>Diagnostic Test: Blood test for estradiol at coordination scan<br>* Blood test<br>Diagnostic Test: Endometrial blood flow (doppler) at ET<br>* Ultrasound scan<br>Diagnostic Test: Endometrial blood flow (doppler) at coordination scan<br>* Ultrasound scan<br>Diagnostic Test: Contractility at embryo transfer on a subgroup of participants<br>* Ultrasound scan<br>Diagnostic Test: Change in endometrial pattern between coordination scan and ET<br>* Ultrasound scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In Vitro Fertilisation (IVF), Intra Cytoplasmic Injection (ICSI), Endometrial Pattern, Ultrasound