Efficacy of Acupuncture for Diminished Ovarian Reserve: A Randomized Controlled Trial Protocol.
Study Goal
The researchers aimed to determine whether acupuncture could effectively relieve age-related decline in female fertility, specifically in women with diminished ovarian reserve (DOR), by assessing changes in ovarian function markers and psychological metrics.
Results Summary
The study is designed to compare acupuncture and sham acupuncture in improving ovarian function (measured by FSH, AMH, AFC, and serum sex hormone levels) and reducing anxiety and depression scores in women with DOR. Results are expected but not yet reported, and the study includes rigorous monitoring of adverse events to ensure safety.
Population
108 women in China diagnosed with diminished ovarian reserve (DOR).
Effective Dosage
Acupuncture treatments three times a week, each lasting 30 minutes.
Duration
36 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
acupuncture | decrease | age-related decline in female fertility | women with diminished ovarian reserve (DOR) | - | relieve | #1 |
acupuncture | decrease | age-related decline in female fertility | women with diminished ovarian reserve (DOR) | - | assess whether can successfully relieve | #2 |
acupuncture | neutral | ovarian function modeling | patients with DOR | - | measure the effectiveness | #3 |
acupuncture | neutral | antral follicle count (AFC) | patients with DOR | - | measure the effectiveness | #4 |
acupuncture | neutral | serum sex hormone levels | patients with DOR | - | measure the effectiveness | #5 |
acupuncture | neutral | Zung's Self-rating Anxiety Scale (SAS) | patients with DOR | - | measure the effectiveness | #6 |
acupuncture | neutral | Self-rating Depression Scale (SDS) | patients with DOR | - | measure the effectiveness | #7 |
acupuncture | neutral | age-related decline in female fertility | patients with DOR | - | whether is superior to sham acupuncture | #8 |
BACKGROUND: With diminished ovarian reserve (DOR) becoming increasingly younger in women, age-related fertility decline in females is gradually becoming one of the most important factors affecting female fertility. The purpose of the study is to assess whether acupuncture can successfully relieve the age-related decline in female fertility. This will provide substantial proof in support of the therapeutic effectiveness of acupuncture. METHODS: This is a randomized, double-blind, controlled trial. There will be 108 participants diagnosed with DOR recruited in China. Participants will be randomly assigned in a 1:1 ratio to two groups, including acupuncture and sham acupuncture groups. The participants will receive acupuncture treatments three times a week, each lasting 30 minutes, for 36 weeks. The primary outcome was the change in ovarian function modeling as assessed by four metrics: age, ovarian reserve markers such as follicle-stimulating hormone (FSH) and anti-Müllerian hormone (AMH) in the Ovarian Reserve Function Prediction Tool (OvaRePred). Secondary outcomes will include changes in the antral follicle count (AFC), serum sex hormone levels, Zung's Self-rating Anxiety Scale (SAS), and the Self-rating Depression Scale (SDS). Adverse events (AEs) associated with acupuncture will be documented following each treatment session. AEs will be monitored and reported to ensure patient safety throughout the trial. EXPECTED RESULTS AND CONCLUSION: We will be able to measure the effectiveness of acupuncture for patients with DOR and whether acupuncture is superior to sham acupuncture. The proposed acupuncture treatment might provide an alternative option for those patients. TRIAL REGISTRATION NUMBER: ChiCTR2400086376.