Tokyo, Sept. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062891) titled 'Blastocyst Outcomes Study for NAD+ Supplementation Of embryo Media' on Sept. 11.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - No treatment

Primary Sponsor: Institute - Jumpstart Fertility Pty Ltd

Condition: Condition - Human infertility; preimplantation embryo development and blastocyst quality in assisted reproduction (in-vitro study on donated cryopreserved 2PN embryos). Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Despite advances in assisted reproduction and in vitro fertilisation (IVF), less than half of normally fertilised zygotes reach the blastocyst stage, so the supply of good quality blastocysts remains a principal limit on IVF success. NAD+ is a central metabolic cofactor whose availability falls with reproductive ageing, and in animal studies, supplementation with NAD+ precursors in culture media improves embryo development and blastocyst formation. The "Blastocyst Outcomes Study for NAD+ Supplementation of Embryo Media (BLOSSOM)" trial will evaluate the safety and preliminary efficacy of adding JSF001 to human embryo culture medium.

This trial will be conducted in cryopreserved 2PN human zygotes that have been donated for research, which would otherwise be discarded. These 2PN embryos will be thawed and randomly split into embryo culture media with or without JSF001, and then cultured to measure the proportion in each group reaching blastocyst development. As embryos from within each collection cycle from a single patient are randomly split into media with or without JSF001, each patient and cycle will act as its own control. The trial will measure the impact of JSF001 supplementation on embryo development outcomes including blastocyst development, blastocyst quality and aneuploidy.

An initial pilot phase will test JSF001 across four clinically used base media products, to be followed by a confirmatory phase. We will determine whether JSF001 increases the proportion of embryos reaching good quality blastocyst status, analysed by a generalised linear mixed model that accounts for the clustering of sibling embryos within patients. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Experimental (with JSF001). Within each patient, sibling 2PN embryos will be randomised 1:1 to culture with or without JSF001, so that each patient acts as their own control. Embryos allocated to the experimental group will be cultured from Day 1 (post-thaw) to Day 6 in the base culture medium pre-formulated with the NAD precursor JSF001 in well-of-the-well dishes under standard conditions. In the pilot phase, JSF001 will be tested across four base media formulations. Interventions/Control_2 - Control (without JSF001). The sibling embryos allocated to control will be cultured identically in the same base culture medium without JSF001 in a different well-of-the-well dish, and in the pilot phase across the same four base media. Allocation between the two conditions will be concealed from the embryologists grading morphology through coded labelling of dishes.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Embryos: cryopreserved 2PN embryos surplus to clinical need and otherwise destined for disposal; donated for research with informed consent from the gamete providers; created by IVF or ICSI (method to be recorded as a covariate) using fresh or frozen ejaculated sperm (source to be recorded as a covariate). All maternal age groups are eligible; the pilot phase will draw from maternal ages 30-31, 37-38 or 40-41 years at retrieval. Maternal age at retrieval will be recorded for every embryo and used as a covariate in the analysis. Gamete donors: provided written informed consent for research donation; embryos created during standard IVF treatment at Asada Ladies Clinic. Key exclusion criteria - Abnormally fertilised embryos (1PN, 3PN or other abnormal fertilisation); embryos from surgically retrieved or non-ejaculated sperm (for example MESA, TESE); cycles using oocyte activation; cryopreserved or thawed oocytes; embryos from cycles without research consent; embryos that would not otherwise be discarded. Whole-embryo PGT-A will additionally not be performed on embryos that have degenerated or undergone apoptosis before collection, because DNA degradation impairs PGT-A. Target Size - 1000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 11 Day Date of IRB - 2026 Year 05 Month 20 Day Anticipated trial start date - 2026 Year 09 Month 14 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072002

Disclaimer: Curated by HT Syndication.