Adjunctive effects of acupuncture and moxibustion in women with premature ovarian insufficiency receiving hormone replacement therapy: protocol for a multicenter, assessor-blinded, 2 × 2 factorial randomized controlled trial
- 1School of Acupuncture-Moxibustion and Tuina, Guizhou University of Traditional Chinese Medicine
- 2Acupuncture and Moxibustion, The First Affiliated Hospital of Guizhou University of Chinese Medicine
Abstract
Introduction: Premature ovarian insufficiency (POI) is characterized by impaired ovarian function before 40 years of age and is associated with menstrual disturbance, infertility, hypoestrogenic symptoms, psychological distress, and long-term health risks. Hormone replacement therapy (HRT) is recommended for symptom control and prevention of estrogen-deficiency-related complications but does not reliably restore ovarian activity or fertility potential. Acupuncture and moxibustion are used as complementary interventions for ovarian dysfunction; however, evidence regarding their independent and combined adjunctive effects in women with POI remains limited.
Methods: This prospective, multicenter, assessor-blinded, 2 × 2 factorial randomized controlled trial will recruit 144 women with POI from three clinical centers. Participants will be randomly assigned in a 1:1:1:1 ratio to estradiol/dydrogesterone alone, acupuncture plus estradiol/dydrogesterone, moxibustion plus estradiol/dydrogesterone, or combined acupuncture and moxibustion plus estradiol/dydrogesterone. The intervention period will last 12 weeks. The primary outcome is the change from baseline to week 12 in antral follicle count (AFC). Secondary outcomes include serum anti-Müllerian hormone (AMH), sex hormones, ovarian hemodynamic parameters, menopausal and anxiety symptoms, Traditional Chinese Medicine syndrome scores, and menstrual status. Clinical pregnancy will be analyzed as an exploratory reproductive outcome during treatment and follow-up at weeks 24 and 48. Factorial models will estimate the main effects of acupuncture and moxibustion, whereas the acupuncture × moxibustion interaction will be considered exploratory.
Conclusion: This trial will evaluate the adjunctive effects of acupuncture and moxibustion on AFC and related secondary clinical outcomes in a selected subgroup of women with POI receiving standard HRT. The factorial design will permit estimation of the independent effects of both interventions and exploratory assessment of their potential interaction.
Clinical trial number: https://itmctr.ccebtcm.org.cn/ , identifier ITMCTR2025002408.
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BibTeX
@article{lu2026adjunctive,
title = {{Adjunctive effects of acupuncture and moxibustion in women with premature ovarian insufficiency receiving hormone replacement therapy: protocol for a multicenter, assessor-blinded, 2 × 2 factorial randomized controlled trial}},
author = {Chunxia Lu and Tingting Ye and Jin Cui and Bo Chen},
journal = {Frontiers in Endocrinology},
year = {2026},
month = oct,
doi = {10.3389/fendo.2026.1952726},
url = {https://www.frontiersin.org/articles/10.3389/fendo.2026.1952726/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Adjunctive effects of acupuncture and moxibustion in women with premature ovarian insufficiency receiving hormone replacement therapy: protocol for a multicenter, assessor-blinded, 2 × 2 factorial randomized controlled trial
AU - Chunxia Lu
AU - Tingting Ye
AU - Jin Cui
AU - Bo Chen
PY - 2026
DA - 2026/10/19
JO - Frontiers in Endocrinology
DO - 10.3389/fendo.2026.1952726
UR - https://www.frontiersin.org/articles/10.3389/fendo.2026.1952726/full
AB - Introduction: Premature ovarian insufficiency (POI) is characterized by impaired ovarian function before 40 years of age and is associated with menstrual disturbance, infertility, hypoestrogenic symptoms, psychological distress, and long-term health risks. Hormone replacement therapy (HRT) is recommended for symptom control and prevention of estrogen-deficiency-related complications but does not reliably restore ovarian activity or fertility potential. Acupuncture and moxibustion are used as complementary interventions for ovarian dysfunction; however, evidence regarding their independent and combined adjunctive effects in women with POI remains limited. Methods: This prospective, multicenter, assessor-blinded, 2 × 2 factorial randomized controlled trial will recruit 144 women with POI from three clinical centers. Participants will be randomly assigned in a 1:1:1:1 ratio to estradiol/dydrogesterone alone, acupuncture plus estradiol/dydrogesterone, moxibustion plus estradiol/dydrogesterone, or combined acupuncture and moxibustion plus estradiol/dydrogesterone. The intervention period will last 12 weeks. The primary outcome is the change from baseline to week 12 in antral follicle count (AFC). Secondary outcomes include serum anti-Müllerian hormone (AMH), sex hormones, ovarian hemodynamic parameters, menopausal and anxiety symptoms, Traditional Chinese Medicine syndrome scores, and menstrual status. Clinical pregnancy will be analyzed as an exploratory reproductive outcome during treatment and follow-up at weeks 24 and 48. Factorial models will estimate the main effects of acupuncture and moxibustion, whereas the acupuncture × moxibustion interaction will be considered exploratory. Conclusion: This trial will evaluate the adjunctive effects of acupuncture and moxibustion on AFC and related secondary clinical outcomes in a selected subgroup of women with POI receiving standard HRT. The factorial design will permit estimation of the independent effects of both interventions and exploratory assessment of their potential interaction. Clinical trial number: https://itmctr.ccebtcm.org.cn/ , identifier ITMCTR2025002408.
SN - 1664-2392
ER -