- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03860636
The Accuracy of Endometrial Ultrasound to Predict Implantation
The Prognostic Accuracy of Within Cycle, Pre-embryo Transfer, Ultrasound Endometrial Patterns, to Predict Implantation During Assisted Reproduction
Study Overview
Status
Conditions
Intervention / Treatment
- 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
- Diagnostic test: Endometrial Pattern on Ultrasound at co-ordination scan
- Diagnostic test: Endometrial thickness at coordination scan
- Diagnostic test: Endometrial volume at coordination scan
- 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 coordination scan
- Diagnostic test: Endometrial blood flow (doppler) at coordination scan
- Diagnostic test: Change in endometrial pattern between coordination scan and ET
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Nicholas Raine-Fenning, MBChB MRCOG PhD
- Phone Number: +441158961900
- Email: nick.raine-fenning@nottingham.ac.uk
Study Contact Backup
- Name: Hiba Elhassan, MBBS BSc (Hons) MRCOG
- Email: hiba.elhassan@nottingham.ac.uk
Study Locations
-
-
Nottinghamshire
-
Nottingham, Nottinghamshire, United Kingdom, NG10 5QG
- Recruiting
- Nurture Fertility
-
Contact:
- Hiba Elhassan, MBBS BSc (Hons) MRCOG
- Email: hiba.elhassan@nottingham.ac.uk
-
Contact:
- Nicholas Raine-Fenning, MBChB PhD
- Email: nick.raine-fenning@nottingham.ac.uk
-
Principal Investigator:
- Nicholas Raine-Fenning, MBChB PhD
-
Sub-Investigator:
- Hiba Elhassan, MBBS BSc MRCOG
-
Sub-Investigator:
- Jim Thornton, Prof of Obs & Gynae, MD, FRCOG
-
Sub-Investigator:
- Walid Maalouf, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Ultrasound scan
Ultrasound
Ultrasound
Ultrasound
Ultrasound
Ultrasound scan
Ultrasound scan
Ultrasound scan
Ultrasound scan
Blood test
Blood test
Blood test
Blood test
Blood test
Blood test
Ultrasound scan
Ultrasound scan
Ultrasound scan
Ultrasound scan
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.
|
Ultrasound scan
Ultrasound scan
Ultrasound scan
Blood test
Blood test
Ultrasound scan
Ultrasound scan
Ultrasound
Ultrasound scan
Ultrasound scan
Blood test
Ultrasound scan
Blood test
Ultrasound scan
Ultrasound scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
Time Frame: Within 10 weeks after embryo transfer
|
Ectopic pregnancy resulting from the treatment cycle
|
Within 10 weeks after embryo transfer
|
Number of biochemical pregnancies
Time Frame: Within 6 weeks after embryo tranfer
|
Biochemical pregnancy resulting from the treatment cycle
|
Within 6 weeks after embryo tranfer
|
Number of miscarriages
Time Frame: Within 12 weeks after embryo transfer
|
Miscarriage resulting from the treatment cycle
|
Within 12 weeks after embryo transfer
|
Number of live birth
Time Frame: Within one year after embryo transfer
|
Live birth resulting from the treatment cycle
|
Within one year after embryo transfer
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicholas Raine-Fenning, MBChB MRCOG PhD, University of Nottingham, Nurture Fertility Director
Publications and helpful links
General Publications
- Coats E, Carden H, Zujovic L, Maalouf W, Hopkisson J, Raine-Fenning N. Qualifying the difficulty of embryo transfer with a visual analogue scale and assessing its impact on IVF outcomes. Hum Fertil (Camb). 2019 Sep;22(3):177-181. doi: 10.1080/14647273.2018.1434903. Epub 2018 Feb 19.
- Richardson A, Brearley S, Ahitan S, Chamberlain S, Davey T, Zujovic L, Hopkisson J, Campbell B, Raine-Fenning N. A clinically useful simplified blastocyst grading system. Reprod Biomed Online. 2015 Oct;31(4):523-30. doi: 10.1016/j.rbmo.2015.06.017. Epub 2015 Jul 8.
- Richardson A, Brearley S, Ahitan S, Chamberlain S, Davey T, Zujovic L, Hopkisson J, Campbell B, Raine-Fenning N. Temporal validation of a simplified blastocyst grading system. Hum Fertil (Camb). 2017 Jun;20(2):113-119. doi: 10.1080/14647273.2016.1255355. Epub 2016 Nov 28.
- Raine-Fenning NJ, Campbell BK, Clewes JS, Kendall NR, Johnson IR. The reliability of virtual organ computer-aided analysis (VOCAL) for the semiquantification of ovarian, endometrial and subendometrial perfusion. Ultrasound Obstet Gynecol. 2003 Dec;22(6):633-9. doi: 10.1002/uog.923.
- Raine-Fenning N, Campbell B, Collier J, Brincat M, Johnson I. The reproducibility of endometrial volume acquisition and measurement with the VOCAL-imaging program. Ultrasound Obstet Gynecol. 2002 Jan;19(1):69-75. doi: 10.1046/j.0960-7692.2001.00608.x.
- Jones NW, Raine-Fenning NJ, Mousa HA, Bradley E, Bugg GJ. Evaluating the intra- and interobserver reliability of three-dimensional ultrasound and power Doppler angiography (3D-PDA) for assessment of placental volume and vascularity in the second trimester of pregnancy. Ultrasound Med Biol. 2011 Mar;37(3):376-85. doi: 10.1016/j.ultrasmedbio.2010.11.018. Epub 2011 Jan 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infertility
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Progestins
- Estradiol
- Progesterone
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
Other Study ID Numbers
- REC 87-1808
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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