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Exploring the efficacy and safety of acupuncture versus sham acupuncture for diminished ovarian reserve: study protocol for a multicentre randomised controlled trial.

BMJ open
January 1, 1970
Qiwei Xiao et al. (16 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

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

Extracted Claims (10)
InterventionDirectionEndpointPopulationDosageImpactClaim #
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
Abstract

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.

Medical Subject Headings (MeSH)
AdultFemaleHumansPregnancyAcupuncture TherapyAnti-Mullerian HormoneChinaEmbryo TransferFertilization in VitroFollicle Stimulating HormoneInfertility, FemaleMulticenter Studies as TopicOvarian FollicleOvarian ReservePregnancy RateRandomized Controlled Trials as TopicTreatment Outcome
Study Links
Quality Scores
SafetyNot Assessed
Quality85/10
Research Impact Scores
APT Score0.05
Weight Score1.39
Normalized Score0.57
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