The Accuracy of Endometrial Ultrasound to Predict Implantation

Infertility, Subfertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03860636
• Other study ID #: REC 87-1808
• Status: Recruiting
• Start date: November 26, 2018
• Est. completion date: April 2022

Study information

• Verified date: September 2021
• Source: University of Nottingham
• Contact: Nicholas Raine-Fenning, MBChB MRCOG PhD
• Phone: +441158961900
• Email: nick.raine-fenning[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Subfertility

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
United Kingdom	Nurture Fertility	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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: 10.1080/14647273.201 — View Citation

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 — View Citation

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. — View Citation

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):6 — View Citation

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 2 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of ectopic pregnancies	Ectopic pregnancy resulting from the treatment cycle	Within 10 weeks after embryo transfer
Secondary	Number of biochemical pregnancies	Biochemical pregnancy resulting from the treatment cycle	Within 6 weeks after embryo tranfer
Secondary	Number of miscarriages	Miscarriage resulting from the treatment cycle	Within 12 weeks after embryo transfer
Secondary	Number of live birth	Live birth resulting from the treatment cycle	Within one year after embryo transfer