Multifaceted Benefits of Auricular Point Sticking for IVF Patients: Psychological Well-being, Sleep, and Treatment Outcomes

Summary

The goal of this clinical trial is to evaluate whether the complementary intervention of auricular point sticking therapy (APST) can improve pregnancy outcomes by ameliorating psychological distress and sleep quality in female patients aged 20-45 years undergoing in-vitro fertilization and embryo transfer (IVF-ET) who also present with anxiety and/or insomnia.

The main questions it aims to answer are:

Does the addition of APST to standard luteal phase support improve key IVF-ET pregnancy outcomes (embryo implantation rate, clinical pregnancy rate, ongoing pregnancy rate)? Does APST effectively reduce anxiety and depression scores (measured by GAD-7 and PHQ-9) and improve sleep quality (measured by PSQI and actigraphy) in this patient population? Are the observed clinical improvements associated with modulation of stress-related biomarkers (e.g., serum cortisol, 5-HT)? Researchers will compare the intervention group (standard care + APST) to the control group (standard care only) to see if the combined therapy leads to superior outcomes in psychological well-being, sleep parameters, and ultimately, reproductive success.

Participants will be randomly assigned to either the control group or the intervention group.

In the control group, receive standard luteal phase support medication (e.g., progesterone injections or oral dydrogesterone) for 4 weeks post-embryo transfer.

In the intervention group, receive the same standard medication plus auricular point sticking therapy. This involves: 1.Having vaccaria seeds attached to specific ear acupoints (Heart, Liver, Endocrine, Shenmen, Subcortex, Sympathetic). 2.Performing self-acupressure on the seeds 3 times daily for 3 minutes each session. 3.Replacing the seeds at a new site every 3 days. 4.Complete psychological (GAD-7, PHQ-9) and sleep quality (PSQI) questionnaires at baseline and 12 weeks post-transfer. 5.Wear an actigraphy device on the wrist for 7 consecutive days to objectively monitor sleep patterns. 6.Provide blood samples for biomarker analysis (cortisol, 5-HT) on specific days post-transfer. 7.Undergo follow-up assessments to determine pregnancy status (β-hCG test, ultrasound).

Conditions

• Infertility, Female
• Anxiety
• Assisted Reproductive Techniques
• Dyssomnias
• Depression

Interventions

OTHER

auricular point sticking therapy

Patients in the intervention group will receive the same artificial cycle therapy as the control group, combined with Auricular Point Sticking Therapy (APST).Auricular Point Sticking Therapy Procedure: Unilateral ear acupoints-Heart (CO15), Liver (CO12), Endocrine (CO18), Shenmen (TF4), Subcortex (AT4), and Sympathetic (AH6a)-are selected. The auricle is disinfected using an alcohol-saturated cotton swab. After the alcohol evaporates, a Vaccaria segetalis seed patch is applied to each designated acupoint using forceps and secured. Following application, appropriate digital pressure is applied to each point until a local sensation of warmth, soreness, numbness, distension, or pain (Deqi sensation) is achieved.

DRUG

Conventional Artificial Cycle Therapy

Patients in the control group will receive artificial cycle therapy post-IVF-ET: progesterone injection 40 mg/day, or oral dydrogesterone tablets (Duphaston) 20 mg/day, or progesterone soft capsules 200 mg/day.

Sponsors & Collaborators

• Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University

  lead OTHER

Principal Investigators

• Jing Ma · Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-31

Primary Completion

2026-10-31

Completion

2026-12-31

Countries

• China

Study Locations