Biomarkers predictive of embryo quality and assisted reproductive treatment outcomes

Potential participants are identified and recruited consecutively from new bookings, with a note to the site nurse to provide information about the trial either via a phone call or during the patient's orientation and information session. On day 2 of menses, the consented female participants are scheduled for a blood test as part of routine care, at which point an additional venous blood samples is collected for proteomic biomarker screening. The following paragraph constitutes routine/standard care for participant at the discretion of the patient's doctor. Female participants undergoing IVF or ICSI by the antagonist treatment protocol consists of follicle-stimulating hormone (FSH) and lutenizing hormone (LH) injections. Starting around the fifth day, the Gonadotropin-Releasing Hormone (GnRH) antagonist is added to prevent premature ovulation. The b-hCG triggered is administers and 36-38 hours later oocytes are collected. Fertilisation occurs by IVF or ICSI, embryos are selected using AI score between days 3 - 5 post-fertilisation and frozen or transferred to female patient. Biochemical pregnancy test is performed after 2 weeks implantation, clinical pregnancy after 6 weeks and miscarriage monitoring up to 20 weeks gestation by obtaining patient records. Upon receipt of the patient consent form, the female participant receives the questionnaire by email. Questions to ascertain a patient’s probability of a spontaneous pregnancy within 1 year were included as a baseline/benchmark as a comparator to our model prediction. A semi-quantitative food frequency questionnaire (FFQ), was modified to include food groups with know effects on embryo quality and pre-pregnancy supplementation recommendations. In addition, the survey contains questions to refine the clinical utility of a predictive model from the patient's perspective. Female and male patient records will collected at the periodically throughout the study, including comorbidities, hormonal stimulation, embryological pathologies and pregnancy outcomes. No further active involvement from the patient is required. With exception of the additional blood collection for proteomic analysis and the completion of a questionnaire, all treatment/procedures are part of routine care