Exploring the efficacy and safety of acupuncture versus sham acupuncture for diminished ovarian reserve: study protocol for a multicentre randomised controlled trial.
Study Goal
The researchers aimed to evaluate the efficacy and safety of acupuncture in improving ovarian function and IVF outcomes in women with diminished ovarian reserve (DOR).
Results Summary
The study is ongoing, so no results are reported in the abstract. Outcomes to be measured include changes in antral follicle count, hormone levels, anxiety scores, and IVF-related outcomes.
Population
400 women with diminished ovarian reserve (DOR) across seven hospitals in China.
Effective Dosage
36 sessions over 12 weeks (frequency not specified).
Duration
12 weeks (with follow-up at 24 weeks).
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
acupuncture | neutral | ovarian reserve | women with diminished ovarian reserve (DOR) | - | evaluating | #1 |
acupuncture | neutral | in vitro fertilisation (IVF) outcomes | women with diminished ovarian reserve (DOR) | - | evaluating | #2 |
acupuncture | neutral | change in antral follicle count (AFC) | women with DOR | - | will be evaluated | #3 |
acupuncture | neutral | AFC | women with DOR | - | will be evaluated | #4 |
acupuncture | neutral | serum levels of basal follicle-stimulating hormone | women with DOR | - | will be evaluated | #5 |
acupuncture | neutral | serum levels of anti-Mullerian hormone | women with DOR | - | will be evaluated | #6 |
acupuncture | neutral | scores of the Self-Rating Anxiety Scale | women with DOR | - | will be evaluated | #7 |
acupuncture | neutral | clinical pregnancy rate | women with DOR | - | will be evaluated | #8 |
acupuncture | neutral | IVF embryo transfer related outcomes | women with DOR | - | will be evaluated | #9 |
acupuncture | neutral | adverse events | women with DOR | - | will be documented | #10 |
INTRODUCTION: The therapeutic needs of women with diminished ovarian reserve (DOR), coupled with the increasing application of acupuncture in improving ovarian function, have highlighted the need to verify the efficacy and safety of acupuncture for DOR. This study aims to provide high-quality evidence by evaluating both ovarian reserve and in vitro fertilisation (IVF) outcomes. METHODS AND ANALYSIS: A large-scale, multicentre, randomised controlled trial will be carried out across seven hospitals in China. 400 women with DOR will be randomised in a 1:1 ratio to an acupuncture group or a sham acupuncture group. Acupuncture or sham acupuncture will consist of 36 sessions per participant over 12 weeks. The primary outcome will be the change in antral follicle count (AFC) at week 12 from baseline. Secondary outcomes are AFC at week 24, the serum levels of basal follicle-stimulating hormone and anti-Mullerian hormone at weeks 12 and 24, the scores of the Self-Rating Anxiety Scale at weeks 12 and 24, clinical pregnancy rate, and IVF embryo transfer related outcomes. Any adverse events during treatment will be documented. ETHICS AND DISSEMINATION: The study protocol has been approved by all the participating institutions. Written informed consent will be obtained prior to participant enrolment. The results of this study will be published in peer-reviewed publications. TRIAL REGISTRATION NUMBER: ChiCTR2200062295 PROTOCOL VERSION: V2.0-20220317.