Clinical trial NCT03860636: The Accuracy of Endometrial Ultrasound to Predict Implantation
Official title: The Prognostic Accuracy of Within Cycle, Pre-embryo Transfer, Ultrasound Endometrial Patterns, to Predict Implantation During Assisted Reproduction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Subfertility
Keywords: In Vitro Fertilisation (IVF)
Intra Cytoplasmic Injection (ICSI)
Endometrial Pattern
Ultrasound
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 155
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of clinical pregnancies
timeFrame: Within 12 weeks after embryo transfer (usually scan performed at 6-7 weeks gestation)
Secondary outcomes:
measure: Number of ectopic pregnancies
timeFrame: Within 10 weeks after embryo transfer
measure: Number of biochemical pregnancies
timeFrame: Within 6 weeks after embryo tranfer
measure: Number of miscarriages
timeFrame: Within 12 weeks after embryo transfer
measure: Number of live birth
timeFrame: Within one year after embryo transfer
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nurture Fertility
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham, Nurture Fertility Director
name: Nicholas Raine-Fenning, MRCOG PhD
role: PRINCIPAL_INVESTIGATOR
References: