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A single-center, randomized, double-blind, placebo-controlled clinical study: Effects of a spermidine-enriched dietary complex supplement on fertility in subjects with spermatogenesis disorders

A single-center, randomized, double-blind, placebo-controlled clinical study: Effects of a spermidine-enriched dietary complex supplement on fertility in subjects with spermatogenesis disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077972
Enrollment
Unknown
Registered
2023-11-24
Start date
2023-12-01
Completion date
Unknown
Last updated
2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spermatogenic failure

Interventions

Experimental group:Follow the spermatogenic disorder treatment guide + Spermidine-rich dietary complex
Control group:Follow the spermatogenic disorder treatment guide + placebo

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Aged 22-50 years; 2. Individuals who have undergone at least 2 semen analysis examinations and meet one of the following semen parameter criteria: (1) Severe oligoasthenozoospermia: sperm concentration greater than 0, but less than 5×10^6/mL accompanied by asthenozoospermia (asthenozoospermia: the percentage of sperm forward movement in semen <32% or teratozoospermia: normal sperm) Form percentage <4%); (2) Cryptozoospermia: There are no sperm in fresh semen samples, but sperm can be observed by centrifugation microscopy; 3. Participants must express willingness to participate in the study and adhere to the treatment regimen, follow-up, and data collection as per the research protocol.

Exclusion criteria

Exclusion criteria: 1. Participants with bilateral obstructive factors in the reproductive tract, including epididymal obstruction due to epididymitis, congenital absence of vas deferens, ejaculatory duct obstruction, or those with concomitant spermatogenic failure; 2. Participants diagnosed with hypogonadotropic hypogonadism, including idiopathic hypogonadotropic hypogonadism (characterized by reduced FSH, LH), or severe thyroid dysfunction; 3. Participants exhibiting spermatogenic disorders due to the complete deletion of AZFa, AZFb, AZFb+c,on the long arm of the Y chromosome; 4. Participants with verified genetic factors contributing to spermatogenic arrest, including chromosomal abnormalities, pathogenic gene variations, CNV deletions, and other relevant genetic factors; 5. Participants experiencing unmanageable genitourinary infections or malignancies; 6. Participants with a history of drug allergies to the investigational medications; 7. Participants with severe systemic diseases, such as unmanageable hypertension, diabetes, or liver dysfunction despite receiving medical treatment; 8. Female partners aged 42 years; 9. Female partners unwilling to provide essential data or information for female fertility assessment; 10. Female partners with a positive pregnancy test within the last 7 days or self-reported pregnancy; 11. Additional reasons considered ineligible for study inclusion by the investigators.

Design outcomes

Primary

MeasureTime frame
Semen parameters;Pregnancy of the spouse;

Secondary

MeasureTime frame
Semen parameters;Sex hormone level;Spermine and spermidine concentration in seminal plasma;FertiQoL-simplified Chinese;PSQI-simplified Chinese;

Countries

China

Contacts

Public ContactZheng Li

Department of Andrology, the Center for Men's Health, Urologic Medical Center, Shanghai General Hospital

lizhengboshi@sjtu.edu.cn+86 21 6324 0090

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026