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Efficacy of electro-acupuncture on pregnancy outcomes for women undergoing in vitro fertilization: study protocol for a pilot randomized controlled trial.

Frontiers in endocrinologyยทAugust 2024ยทXiaoyan Zheng, Ran Ji, Chaoliang Li et al.
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Key Finding

This pilot study protocol aims to determine if electro-acupuncture during IVF improves clinical pregnancy rates compared to sham acupuncture and IVF alone, though results are not yet available.

What This Means For You

This study is exploring whether electro-acupuncture (EA) can improve pregnancy success rates for women undergoing in vitro fertilization (IVF). Researchers in China are recruiting 118 women struggling with infertility who plan to undergo IVF treatment. Participants will be randomly divided into three groups: one receiving real electro-acupuncture plus IVF, one receiving sham (placebo) electro-acupuncture plus IVF, and one receiving IVF alone. Women in the acupuncture groups will receive treatment three times per week on alternating days throughout their ovarian stimulation period, completing at least five sessions before egg retrieval. The main goal is to determine if electro-acupuncture increases clinical pregnancy rates, defined as ultrasound confirmation of a gestational sac in the uterus. Researchers will also track embryo quality, biochemical pregnancy rates, miscarriage rates, and participants' anxiety, depression, sleep quality, and overall quality of life during treatment. This is a pilot study, meaning it's designed to test whether a larger study is feasible and to gather preliminary data on effectiveness and safety. As this research is still in the protocol stage, no results are yet available. The findings will help clarify whether electro-acupuncture is a worthwhile complementary treatment for women undergoing IVF, addressing the current lack of strong evidence for this increasingly popular practice. If you're considering acupuncture as part of your fertility treatment, consult with a licensed acupuncturist experienced in reproductive health.

Clinical Notes for Practitioners

This pilot RCT investigates electro-acupuncture efficacy for IVF outcomes in infertile women. The three-arm, parallel, sham-controlled trial will randomize 118 participants (1:1:1 ratio) to EA+IVF, placebo EA+IVF, or IVF control groups. The intervention protocol includes three sessions weekly (alternate days) during ovarian stimulation until trigger day, minimum five sessions. Primary outcome measures clinical pregnancy rate (ultrasound-confirmed gestational sac from first fresh/frozen embryo transfer). Secondary outcomes encompass embryology parameters, biochemical pregnancy rate, early miscarriage rate, SAS, SDS, PSQI, FertiQoL scores, retention, adherence, and adverse events. This study addresses the evidence gap regarding EA's role in assisted reproductive technology, responding to patient demand despite limited clinical data. The sham-controlled design and comprehensive psychological assessments strengthen methodological rigor. Results will inform both feasibility of larger trials and preliminary efficacy data for integrative fertility protocols.

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