Tokyo, June 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061986) titled 'Study of the Effects of Kinmemai Consumption on ART Outcomes' on June 25.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - HORAC Grand Front Osaka Clinic

Condition: Condition - Primary infertility Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate the effects of continuous Kinmemai consumption on ART outcomes, including clinical pregnancy and live birth rates, in patients undergoing assisted reproductive technology (ART). In addition, glycation stress markers in follicular fluid and seminal plasma will be assessed to investigate their associations with ART outcomes and to explore potential underlying mechanisms. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will consume Kinmemai as their staple food throughout the study period.

Female participants will consume Kinmemai at least twice daily, and male participants at least once daily.

Consumption will begin at least one month before the initiation of ART treatment and will continue until the first frozen-thawed embryo transfer. Participants who achieve pregnancy following the first frozen-thawed embryo transfer will continue Kinmemai consumption until delivery.

Eligibility: Age-lower limit - 20 years-old

Gender - Female Key inclusion criteria - 1. No previous ART treatment 2. Female age <40 years 3. Nulliparous women 4. Male age <50 years 5. Anti-Mullerian Hormone (AMH) at least 1.0 ng/mL Key exclusion criteria - 1. Serious organic disease 2. Active medical illness 3. Inability to provide informed consent 4. Considered unsuitable by the investigator Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 10 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070863

Disclaimer: Curated by HT Syndication.