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The Accuracy of Endometrial Ultrasound to Predict Implantation

U

University of Nottingham

Status

Completed

Conditions

Infertility, Subfertility

Treatments

Diagnostic Test: Endometrial blood flow (doppler) at HCG
Diagnostic Test: Change in endometrial pattern between HCG and ET
Diagnostic Test: Endometrial blood flow (doppler) at TVOR
Diagnostic Test: Endometrial blood flow (doppler) at coordination scan
Diagnostic Test: Endometrial thickness at coordination scan
Diagnostic Test: Endometrial blood flow (doppler) at ET
Diagnostic Test: Endometrial thickness at HCG
Diagnostic Test: Endometrial volume at ET
Diagnostic Test: Endometrial thickness at ET
Diagnostic Test: Change in endometrial pattern between coordination scan and ET
Diagnostic Test: Blood test for progesterone at coordination scan
Diagnostic Test: Endometrial Pattern on Ultrasound at TVOR
Diagnostic Test: Blood test for progesterone at TVOR
Diagnostic Test: Change in endometrial pattern between TVOR and ET
Diagnostic Test: Blood test for progesterone at ET
Diagnostic Test: Endometrial thickness at TVOR
Diagnostic Test: Endometrial volume at TVOR
Diagnostic Test: Blood test for estradiol at ET
Diagnostic Test: Endometrial Pattern on Ultrasound at co-ordination scan
Diagnostic Test: Endometrial volume at HCG
Diagnostic Test: Blood test for estradiol at coordination scan
Diagnostic Test: Blood test for estradiol at HCG
Diagnostic Test: Blood test for progesterone at HCG
Diagnostic Test: Blood test for estradiol at TVOR
Diagnostic Test: Endometrial Pattern on Ultrasound at HCG
Diagnostic Test: Contractility at embryo transfer on a subgroup of participants
Diagnostic Test: Endometrial Pattern on Ultrasound at ET
Diagnostic Test: Endometrial volume at coordination scan

Study type

Observational

Funder types

Other

Identifiers

NCT03860636
REC 87-1808

Details and patient eligibility

About

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).

Full 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.

Enrollment

155 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

155 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Hiba Elhassan, MBBS BSc (Hons) MRCOG; Nicholas Raine-Fenning, MBChB MRCOG PhD

Data sourced from clinicaltrials.gov

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