UMIN-ICDS Clinical Trial

Public title

Blastocyst Outcomes Study for NAD+ Supplementation Of embryo Media

Acronym

BLOSSOM: Blastocyst Outcomes Study for NAD+ Supplementation Of embryo Media

Scientific Title

Evaluation of the culture medium additive JSF001 on the quality of human blastocysts

Scientific Title:Acronym

BLOSSOM: Blastocyst Outcomes Study for NAD+ Supplementation Of Embryo Media

Region

Japan

Condition

Human infertility; preimplantation embryo development and blastocyst quality in assisted reproduction (in-vitro study on donated cryopreserved 2PN embryos).

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

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

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

The proportion of cultured 2PN embryos reaching Gardner grade at least 3BB (expansion 3 or more, inner cell mass grade B or better, trophectoderm grade B or better) on Day 5 of culture, scored as a binary per-embryo outcome. JSF001 and control embryos will be compared within patients using a binomial generalised linear mixed model with patient as a random effect and maternal age category as a fixed effect.

Key secondary outcomes

- Overall blastocyst formation rate (any grade), expanded-blastocyst rate and Gardner grade at Days 4, 5 and 6.
- Blastocyst formation rate after excluding presumed meiotic aneuploidy, defined as a uniform whole-chromosome gain or loss across the whole embryo on whole-embryo PGT-A.
- Morphokinetics: time to blastulation and expansion by time-lapse imaging.
- Aneuploidy (meiotic and mitotic) by whole-embryo PGT-A of all surviving, non-apoptotic Day 6 embryos.
- Apoptosis: proportion of TUNEL-positive blastomeres in Day 5 fixed embryos.
- Inner cell mass and trophectoderm cell number and allocation by immunofluorescence in Day 5 fixed embryos.
- Embryo degeneration rate and abnormal-development rate.
- Inter-rater reliability of blastocyst grading (intraclass correlation coefficient) between the primary and an independent second assessor.
- Embryologist-preferred ranking: in each split sibling embryo batch, the rate at which a blinded embryologist selects the first-choice embryo for hypothetical transfer from either group.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

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.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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 sample size

1000

Name of lead principal investigator

1st name	Yoshimasa
Middle name
Last name	Asada

Organization

Asada Ladies Clinic

Division name

Asada Ladies Nagoya Ekimae Clinic (Nagoya, Aichi)

Zip code

450-0002

Address

450-0002, Nagoya Building 5F, 4-6-17 Meieki, Nakamura-ku, Nagoya, Aichi, Japan

TEL

81525512203

Email

y_asada@ivf-asada.jp

Name of contact person

1st name	Lindsay
Middle name	E.
Last name	Wu

Organization

Jumpstart Fertility Pty Ltd

Division name

Jumpstart Fertility Pty Ltd

Zip code

2060

Address

1102/2 Elizabeth Plaza, North Sydney, NSW 2060, Australia

TEL

61293851621

Homepage URL

Email

lindsay@jumpstartfertility.com

Institute

Jumpstart Fertility Pty Ltd

Institute

Department

Personal name

Lindsay Wu

Organization

Jumpstart Fertility Pty Ltd

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Australia

Co-sponsor

UNSW Sydney

Name of secondary funder(s)

Organization

Asada Ladies Clinic Ethics Review Committee

Address

450-0002, Nagoya Building 5F, 4-6-17 Meieki, Nakamura-ku, Nagoya, Aichi, Japan

Tel

0525512251

Email

t_kinugawa@ivf-asada.jp

Secondary IDs

YES

Study ID_1

JSOG registration acceptance No. 151

Org. issuing International ID_1

Japan Society of Obstetrics and Gynecology, "Registration for Research Involving Human Sperm, Oocytes and Fertilized Embryos", accepted 26 June 2026. Org issuing ID: JSOG

Study ID_2

JSF001-ALC-2025-01

Org. issuing International ID_2

Jumpstart Fertility

IND to MHLW

No

Institutions

Asada Institute for Reproductive Medicine (Kachigawa),
Asada Ladies Clinic Kachigawa (Aichi),
Asada Ladies Nagoya Station Front Clinic (Aichi),
Asada Ladies Shinagawa Clinic (Tokyo),
ART Clinic ASADA (Aichi)

Date of disclosure of the study information

2026

Year

09

Month

11

Day

URL releasing protocol

osf.io/ed43w

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

Yes

IPD sharing Plan description

De-identified individual participant (embryo-level) data underlying the published primary results may be made available on reasonable request, from 12 months after the primary results are published until 5 years after publication. Sharing is at the sponsor's discretion and is conditional on all of the following: a written request with a methodologically sound proposal specifying a pre-defined analysis consistent with the study's objectives; written approval by the sponsor (Jumpstart Fertility) and Asada Ladies Clinic under the collaboration agreement between them; execution of a data transfer and sharing agreement; approval of the proposed secondary use by the relevant ethics or governance body; and compliance with applicable data-protection requirements. Commercially sensitive and proprietary information, including the identity, formulation and concentration of the study additive, is excluded from any shared dataset. Requesters may be required to meet the costs of data preparation and transfer. Data will not be shared for purposes that conflict with the sponsor's intellectual property or regulatory strategy.

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

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

A pre-specified statistical analysis plan for this study, including the sample size and power calculation and the planned primary and secondary analyses, has been deposited as a time-stamped registration on the Open Science Framework (osf.io/ed43w). The record is currently under embargo and will be released after the primary results are reported; the direct URL and its DOI will be added to this registration once the embargo is lifted.

Registered date

2026

Year

09

Month

11

Day

Last modified on

2026

Year

09

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072002