Shilajit for Male Infertility

Verdict: Weak evidence; not a proven infertility treatment

Shilajit earns a weak (Tier C) rating for male infertility: a few small, mostly industry-linked studies hint at higher testosterone and sperm counts, but the evidence is too thin, and the heavy-metal contamination risk too real, to recommend it as a fertility treatment.

C 🟠 C Weak Evidence Safety Review

🔬Why this grade7-layer evidence engine

The grade is held back by how little direct human evidence exists. Only one trial enrolled men with low sperm counts (Biswas 2010, PMID 20078516), and it was open-label with no placebo group and just 28 completers, so its reported +61.4% sperm count and +23.5% testosterone gains carry low certainty. The one rigorous double-blind RCT (Pandit 2016, PMID 26395129) tested healthy men aged 45-55, not infertile patients, and measured only hormones (total testosterone +20.45%), with no sperm or pregnancy outcomes at all.

Higher-tier evidence is essentially absent. A 2023 systematic review of testosterone boosters (PMID 37697053) judged shilajit only 'possibly effective' for late-onset hypogonadism, again on a testosterone surrogate rather than fertility. The only fertility-specific support comes from a mouse cadmium-toxicity model (PMID 29947420), which is preclinical and not transferable to typical human infertility. No study has measured natural conception or live-birth rates.

Regulators and clinicians reinforce the caution. The AUA/ASRM male-infertility guidance calls supplement benefits of 'questionable clinical utility' with data inadequate to recommend any specific agent, and Cleveland Clinic notes the shilajit studies are over a decade old with very small samples. EFSA treats it as a non-novel supplement without approved health claims, while WHO/Health Canada and the NHS stress purification, capped mineral intake, and avoiding unlicensed herbals because raw shilajit can carry lead, arsenic, cadmium, and mercury.

⚖️

Scoring transparency

All scores computed by a 7-layer evidence engine — fully auditable
Raw score 0.54
D
C
B
A
S
← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
C · Safety Review
Confidence
80%
Highly consistent evidence
Evidence level
E3
Single high-quality meta-analysis

How strongly each layer supports this effect

lower = less supportive
L5 Clinical bodiesAuthoritative stance
0.40
L1 ExamineGlobal benchmark
0.50
L11 AI re-checkIndependent read
0.50
L2 PubMedPrimary literature
0.60
L3 MechanismPlausibility
0.65
Against Mixed Supports
View the full decision path (audit trail)
  1. compute_raw_score — 加權公式: L2×0.30 + L3×0.25 + L5×0.25 + L11×0.10 + L1×0.10 = 0.542
  2. tier_from_score — 依分數區間映射至 tier letter
  3. apply_hec_rules — 無高階證據可裁決
  4. tier_strict_requirement_check — Tier 條件達標,未降階
  5. detect_disputes — 偵測到 0 個 hard + 0 個 soft dispute
  6. decide_status — 依 tier + dispute 結果決定 status

📄PubMed studies (4)L2 · primary research & systematic reviews

Clinical evaluation of spermatogenic activity of processed Shilajit in oligospermia
PMID: 20078516 2010 RCT (open-label) n = 35
Finding: After 90 days: spermia +37.6%, total sperm count +61.4%, motility +12.4-17.4%, normal sperm morphology +18.9% (all P<0.001); serum testosterone +23.5% (P<0.001), FSH +9.4% (P<0.05); seminal MDA -18.7% (lower oxidative stress). Hepatic/renal panels unchanged; no adverse effects.
🟠 Limited quality Academic Effect size: [object Object]
View on PubMed
Clinical evaluation of purified Shilajit on testosterone levels in healthy volunteers
PMID: 26395129 2016 RCT (double-blind) n = 96
Finding: Vs placebo at 90 days, Shilajit significantly (P<0.05) increased total testosterone (reported +20.45%), free testosterone (+19.14%), and DHEAS (+31.35%); LH and FSH well maintained (no HPG-axis suppression). Surrogate endpoint for male reproductive health; no sperm parameters or fertility outcomes measured.
Academic Effect size: [object Object]
View on PubMed
Do 'testosterone boosters' really increase serum total testosterone? A systematic review
PMID: 37697053 2023 系統性回顧
Finding: Most testosterone boosters fail to raise serum testosterone. Only beta-hydroxy-beta-methylbutyrate and betaine showed efficacy in male athletes. For Shilajit, authors conclude 'purified Shilajit extract (PrimaVie) can be considered possibly effective for men with late-onset hypogonadism' - graded as limited/possible evidence (not robust). No sperm or fertility endpoint conclusions for Shilajit.
Academic
View on PubMed
Profertility effects of Shilajit on cadmium-induced infertility in male mice
PMID: 29947420 2018 Cohort
Finding: Shilajit dose-dependently reversed cadmium-induced declines in sperm count, motility, and normal morphology; restored serum testosterone and testicular antioxidant capacity; improved histology. Mechanistic/preclinical support only - not directly applicable to idiopathic human male infertility.
🟠 Limited quality Academic
View on PubMed

🏛️Regulatory & authoritative positionsL4/L5 · FDA / EMA / NIH ODS / Cochrane / Mayo …

L4a US FDA
Cautious
L4b EU EFSA
Neutral
Not Novel in Food Supplements (any other Food uses may be considered as Novel). source↗
L4e WHO
Cautious
Shilajit must have undergone a purification process, and the mineral content of Shilajit must be analyzed with daily doses of minerals not exceeding the maximum daily doses as per the NNHPD Multi-Vitamin/Mineral Supplements monograph. source↗
L5c Cleveland Clinic
Cautious
These studies are more than a decade old and have very small sample sizes. More research is needed to determine shilajit's impact on male sex hormones and fertility. source↗
L5e Specialty Society (condition-mapped)
Not addressed
Clinicians should counsel patients that the benefits of supplements (e.g., antioxidants, vitamins) are of questionable clinical utility in treating male infertility. Existing data are inadequate to provide recommendation for specific agents to use for this purpose. source↗
PMID 100% verifiedevery citation checked via NCBI Entrez
🔬4 PubMed studiesindependently re-checked by multiple sub-agents
engine_version: v1.0 claim_id: CLM-COND-male-infertility-INT-shilajit-001 繁體中文版 →