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Purpose <p>To evaluate the efficacy and safety of oral L-ergothioneine (EGT) in improving ovarian reserve and clinical symptoms in women with suboptimal ovarian function. As a proof-of-concept study, we explored correlations between hormonal shifts and symptom amelioration.</p> Methods <p>This single-center, open-label trial enrolled 40 women (aged 35–45&#xa0;years) experiencing age-related reproductive decline (baseline AMH: 1.0–3.0&#xa0;ng/mL) and menstrual disorders. Participants received oral EGT (120&#xa0;mg/day) for three consecutive menstrual cycles. The primary outcome was the change in serum AMH. Secondary outcomes included sex hormones (FSH, E2), antral follicle count, and validated questionnaires (KI, PSQI, SF-36) and an exploratory Menstrual Symptom Score.</p> Results <p>Thirty-six participants completed the intervention without product-related adverse events. EGT supplementation was associated with increases in core ovarian markers: mean AMH increased from 1.81 ± 0.72 to 2.46 ± 1.54&#xa0;ng/mL (mean change + 0.65&#xa0;ng/mL, 95% CI [0.14, 1.17], <i>p</i> = 0.018). Concurrently, basal FSH decreased (8.38 ± 2.83 to 7.05 ± 2.51 mIU/mL, mean change − 1.33, 95% CI [− 2.50, − 0.17]; <i>p</i> = 0.032, FDR-adjusted <i>p</i> = 0.048) and E2 increased (43.78 ± 18.87 to 63.46 ± 50.81&#xa0;pg/mL; mean change + 19.69, 95% CI [3.99, 35.38]; <i>p</i> = 0.019, FDR-adjusted <i>p</i> = 0.048). Clinical assessments showed progressive reductions in KI (5.42 ± 3.66 to 1.90 ± 2.16, <i>p</i> &lt; 0.0001) and PSQI scores (6.89 ± 1.82 to 5.50 ± 1.40, <i>p</i> &lt; 0.0001), alongside improved menstrual and SF-36 scores (<i>p</i> &lt; 0.001). Subgroup analysis stratified by baseline ovarian reserve showed a significant AMH increase in the low-reserve subgroup (<i>p</i> = 0.017) but not the high-reserve subgroup. Exploratory correlation analysis showed that ΔFSH was associated with improvements in sleep quality (ΔPSQI, r = 0.43, <i>p</i> &lt; 0.05) and E2 increases (r = -0.46, <i>p</i> &lt; 0.05), linking hormonal stabilization directly to systemic relief.</p> Conclusion <p>In this open-label, single-arm pilot study, oral EGT supplementation was associated with increases in serum AMH and favorable shifts in the basal FSH/E2 profile, alongside improvements in reproductive aging-related and sleep symptoms. Because the design lacks a control group, these changes cannot be attributed to EGT alone and may partly reflect natural variation, regression to the mean, or placebo effects. These hypothesis-generating findings warrant confirmation in adequately powered, placebo-controlled trials.</p> Trial registration <p>ChiCTR2500104484; Prospectively registered on 2025–06-18.</p>

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Oral L-ergothioneine supplementation in women with suboptimal ovarian reserve: a single-center, open-label, self-controlled pilot study of ovarian reserve markers, endocrine profiles, and reproductive aging-related symptoms

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  • 出版模式：

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  • 发表日期：

    2026年6月17日

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  • Wei Liu,
  • Cong Guo,
  • Wei Ding,
  • Juan Cao,
  • Hongying Ju,
  • Fengjuan Liu,
  • Guohua Xiao

摘要

Purpose

To evaluate the efficacy and safety of oral L-ergothioneine (EGT) in improving ovarian reserve and clinical symptoms in women with suboptimal ovarian function. As a proof-of-concept study, we explored correlations between hormonal shifts and symptom amelioration.

Methods

This single-center, open-label trial enrolled 40 women (aged 35–45 years) experiencing age-related reproductive decline (baseline AMH: 1.0–3.0 ng/mL) and menstrual disorders. Participants received oral EGT (120 mg/day) for three consecutive menstrual cycles. The primary outcome was the change in serum AMH. Secondary outcomes included sex hormones (FSH, E2), antral follicle count, and validated questionnaires (KI, PSQI, SF-36) and an exploratory Menstrual Symptom Score.

Results

Thirty-six participants completed the intervention without product-related adverse events. EGT supplementation was associated with increases in core ovarian markers: mean AMH increased from 1.81 ± 0.72 to 2.46 ± 1.54 ng/mL (mean change + 0.65 ng/mL, 95% CI [0.14, 1.17], p = 0.018). Concurrently, basal FSH decreased (8.38 ± 2.83 to 7.05 ± 2.51 mIU/mL, mean change − 1.33, 95% CI [− 2.50, − 0.17]; p = 0.032, FDR-adjusted p = 0.048) and E2 increased (43.78 ± 18.87 to 63.46 ± 50.81 pg/mL; mean change + 19.69, 95% CI [3.99, 35.38]; p = 0.019, FDR-adjusted p = 0.048). Clinical assessments showed progressive reductions in KI (5.42 ± 3.66 to 1.90 ± 2.16, p < 0.0001) and PSQI scores (6.89 ± 1.82 to 5.50 ± 1.40, p < 0.0001), alongside improved menstrual and SF-36 scores (p < 0.001). Subgroup analysis stratified by baseline ovarian reserve showed a significant AMH increase in the low-reserve subgroup (p = 0.017) but not the high-reserve subgroup. Exploratory correlation analysis showed that ΔFSH was associated with improvements in sleep quality (ΔPSQI, r = 0.43, p < 0.05) and E2 increases (r = -0.46, p < 0.05), linking hormonal stabilization directly to systemic relief.

Conclusion

In this open-label, single-arm pilot study, oral EGT supplementation was associated with increases in serum AMH and favorable shifts in the basal FSH/E2 profile, alongside improvements in reproductive aging-related and sleep symptoms. Because the design lacks a control group, these changes cannot be attributed to EGT alone and may partly reflect natural variation, regression to the mean, or placebo effects. These hypothesis-generating findings warrant confirmation in adequately powered, placebo-controlled trials.

Trial registration

ChiCTR2500104484; Prospectively registered on 2025–06-18.