What question did this study set out to answer?

The aim is to evaluate the effect of acupuncture on clinical pregnancy rates in women with diminished ovarian reserve undergoing IVF-ET.

February 8, 2026Open Access

Effect of acupuncture pretreatment on clinical pregnancy rate in women with diminished ovarian reserve undergoing IVF-ET: study protocol for a multicenter randomized controlled trial

Key Points

The aim is to evaluate the effect of acupuncture on clinical pregnancy rates in women with diminished ovarian reserve undergoing IVF-ET.
Multicenter, randomized, placebo-controlled trial with 300 women.
Participants randomized 1:1 to acupuncture or placebo acupuncture.
Interventions start from the second menstrual cycle until oocyte retrieval.
Primary outcome is the clinical pregnancy rate after the first embryo transfer.
Secondary outcomes include various IVF-ET indicators and ovarian reserve evaluations.
Expected to identify differences in clinical pregnancy rates between acupuncture and placebo groups.
Secondary outcomes will assess IVF-ET indicators like number of follicles and fertilization rates.
Evaluation of improvements in ovarian reserve indicators and anxiety levels anticipated.

Abstract

Introduction Diminished ovarian reserve (DOR) is known to reduce the likelihood of achieving pregnancy or live births in women undergoing in vitro fertilization and embryo transfer (IVF-ET). Acupuncture maybe effective for DOR, but current evidence remains limited and inconclusive. Methods and analysis This study is a multicenter, randomized, placebo-controlled trial conducted on a large scale. A total of 300 women with DOR preparing for IVF-ET will be randomized 1:1 to acupuncture or placebo acupuncture. Interventions will be administered from the second menstrual cycle preceding the IVF cycle until the day of oocyte retrieval. The primary outcome is the clinical pregnancy rate (CPR) following the first embryo transfer. Secondary outcomes include various IVF-ET indicators, such as the number of follicles ≥ 14 mm, estradiol (E2) levels, and endometrial thickness on the day of human chorionic gonadotropin (hCG) administration; the number of retrieved oocytes, metaphase II (MII) oocytes, and two pronuclei (2PN) fertilizations; as well as the rates of 2PN fertilization, available embryos, high-quality embryos, implantation, cycle cancellation, biochemical pregnancy, pregnancy loss, sustained pregnancy, and live birth. Additionally, ovarian reserve indicators—including antral follicle count (AFC), basal serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), and E2, and anti-Müllerian hormone (AMH)—along with scores from the Self-Rating Anxiety Scale (SAS) will also be evaluated. Ethics and dissemination The trial has been approved by the ethics committees of all participating centers. The results will be disseminated in academic journals. Clinical Trial Registration http://itmctr.ccebtcm.org.cn/ , identifier ID: ITMCTR2024000021.

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