The Synergistic Ameliorative Effects of Auricular Point Sticking Therapy on the Psychological Well-being, Sleep Quality, and Pregnancy Outcomes of IVF Patients
概览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Embryo implantation rate
概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1.Diagnostic Criteria for Infertility
- •The diagnosis is established in accordance with \*Obstetrics and Gynecology (10th Edition)\* and the \*Guidelines for Diagnosis and Treatment of Infertility (2019)\*. To be eligible, patients must meet the following criteria:
- •Be a woman of reproductive age, between 20 and 45 years old;
- •Have failed to achieve a clinical pregnancy after ≥12 months of regular, unprotected intercourse (or ≥6 months for women aged ≥35).
- •Furthermore, the indication for IVF-ET must be met by satisfying at least one of the following conditions:
- •Ovulatory factor infertility (e.g., hypothalamic amenorrhea or menstrual disorders, pituitary amenorrhea or menstrual disorders, ovarian amenorrhea or menstrual disorders, other endocrine disorders);
- •Pelvic factor infertility (e.g., congenital anomalies of the reproductive system, cervical factors, uterine disorders, tubal and/or peritoneal factors, endometriosis);
- •Male factor infertility (e.g., azoospermia, oligospermia, asthenospermia, teratospermia, isolated abnormal seminal plasma);
- •Unexplained infertility.
- •2\. Diagnostic Criteria for Anxiety State
排除标准
- •(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.
研究组 & 干预措施
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.
干预措施: Conventional Artificial Cycle Therapy (Drug)
Conventional artificial cycle therapy will be supplemented with 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.
干预措施: auricular point sticking therapy (Other)
Conventional artificial cycle therapy will be supplemented with 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.
干预措施: Conventional Artificial Cycle Therapy (Drug)
结局指标
主要结局
Embryo implantation rate
时间窗: 12 days after embryo transfer
defined as serum β-hCG ≥ 50 IU/L on day 12 after embryo transfer
Clinical pregnancy rate
时间窗: 28 days after embryo transfer
confirmed by the presence of at least one intrauterine gestational sac on transvaginal ultrasound
Generalized Anxiety Disorder 7-item scale
时间窗: Baseline and 4 weeks after embryo transfer
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).
Patient Health Questionnaire-9 Score
时间窗: Baseline and 4 weeks after embryo transfer
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).
Pittsburgh Sleep Quality Index
时间窗: Baseline and 4 weeks after embryo transfer
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).
Change in objective sleep parameters measured by actigraphy
时间窗: Baseline and 4 weeks after embryo transfer
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.
serum cortisol levels
时间窗: Fasting morning venous blood samples are collected at 2 days (baseline) and 12 days after embryo transfer for analysis.
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
Serum serotonin (5-HT) levels
时间窗: Fasting morning venous blood samples are collected at 2 days (baseline) and 12 days after embryo transfer for analysis.
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.
次要结局
- 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)
研究者
Ying Zhu
Gynecologist
Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University