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

NCT07409792 | Enrolling By Invitation

• 1 other identifier: 2025KLL180
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (8)

• Embryo implantation rate

  defined as serum β-hCG ≥ 50 IU/L on day 12 after embryo transfer

  12 days after embryo transfer

• Clinical pregnancy rate

  confirmed by the presence of at least one intrauterine gestational sac on transvaginal ultrasound

  28 days after embryo transfer

• Generalized Anxiety Disorder 7-item scale

  The Generalized Anxiety Disorder 7-item (GAD-7) scale is a self-reported questionnaire for assessing anxiety severity. It consists of 7 items, each scored from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating worse outcomes (more severe anxiety symptoms).

  Baseline and 4 weeks after embryo transfer

• Patient Health Questionnaire-9 Score

  The Patient Health Questionnaire-9 (PHQ-9) is a self-reported depression screening tool. It consists of 9 items, each scored from 0 to 3. The total score ranges from 0 to 27, with higher scores indicating worse outcomes (more severe depressive symptoms).

  Baseline and 4 weeks after embryo transfer

• Pittsburgh Sleep Quality Index

  The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval. The measure consists of 19 individual items, generating 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is weighted on a 0-3 scale. The global PSQI score is the sum of these 7 component scores, ranging from 0 to 21. A higher total score indicates a worse outcome (poorer sleep quality).

  Baseline and 4 weeks after embryo transfer

• Change in objective sleep parameters measured by actigraphy

  Objective sleep parameters are measured using the Actigraph wGT3X-BT monitor (ActiGraph, USA). Participants wear the device on the non-dominant wrist (left hand) continuously for 7 days and nights. The device is worn daily from 21:00 until 09:00 the following morning. A standardized sleep diary is used concurrently to record lights-off time and wake time. Data are collected at a sampling frequency of 30 Hz and analyzed using ActiLife software (version 7.0.0) to derive parameters such as total sleep time (TST), sleep efficiency (SE), wake after sleep onset (WASO), and sleep latency.

  Baseline and 4 weeks after embryo transfer

• serum cortisol levels

  Serum cortisol concentration is measured in venous blood samples collected in the morning under fasting conditions. Cortisol is a key hormone of the hypothalamic-pituitary-adrenal (HPA) axis, and its level reflects stress response and HPA axis activity. The unit of measurement is nmol/L

  Fasting morning venous blood samples are collected at 2 days (baseline) and 12 days after embryo transfer for analysis.

• Serum serotonin (5-HT) levels

  Serum serotonin (5-HT) concentration is measured in venous blood samples. Serotonin is a key neurotransmitter involved in mood regulation, and its peripheral level is considered a potential biomarker related to psychological stress and emotional states. The unit of measurement is ng/mL.

  Fasting morning venous blood samples are collected at 2 days (baseline) and 12 days after embryo transfer for analysis.

Secondary Outcomes (3)

• Adverse Pregnancy Outcomes

  From embryo transfer up to 12 weeks of gestation

• Local discomfort at auricular acupressure sites assessed by Visual Analogue Scale (VAS)

  From the start of intervention up to 4 weeks

• Incidence of local skin reactions related to auricular acupressure

  From the start of intervention up to 4 weeks

Study Arms (2)

Conventional Artificial Cycle Therapy

ACTIVE COMPARATOR

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.

Drug: Conventional Artificial Cycle Therapy

Conventional artificial cycle therapy will be supplemented with auricular point sticking therapy

EXPERIMENTAL

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.

Other: auricular point sticking therapy; Drug: Conventional Artificial Cycle Therapy

Interventions

auricular point sticking therapy OTHER

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.

Conventional artificial cycle therapy will be supplemented with auricular point sticking therapy

Conventional Artificial Cycle Therapy DRUG

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.

Conventional Artificial Cycle Therapy; Conventional artificial cycle therapy will be supplemented with auricular point sticking therapy

Eligibility Criteria

• Age: 20 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (1) Patients who meet the above diagnostic criteria and have undergone IVF-ET; (2) Female patients aged 20-45 years, with a BMI of 18-28 kg/m²; (3)The embryo to be transferred is a high-quality frozen-thawed embryo (either a Day-3 embryo with ≥8 cells, uniform blastomere size, and fragmentation rate \<10%, or a blastocyst with a grade of ≥3BB); (4) Willing to provide written informed consent and comply with luteal support therapy and follow-up.

You may not qualify if:

• (1) Unauthorized use of sedatives or anxiolytics during the treatment period; (2) Adherence to auricular point sticking therapy less than 80% (based on patient diary records); (3) Cancellation of the frozen embryo transfer cycle (e.g., due to endometrial transformation failure or sudden onset of ovarian hyperstimulation syndrome); (4) The participant voluntarily requests to withdraw from the study.

Sponsors & Collaborators

• Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University: lead

Study Sites (1)

Hangzhou Hospital of Traditional Chinese Medicine

Hangzhou, Zhejiang, 310007, China

Location

MeSH Terms

Conditions

Infertility, Female; Anxiety Disorders; Dyssomnias; Depression

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Jing Ma

  Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologist

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 13, 2026
• Study Start: August 31, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

CN (1)