Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 4:15 AM
Study NCT ID:
NCT07409792
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-13
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multifaceted Benefits of Auricular Point Sticking for IVF Patients: Psychological Well-being, Sleep, and Treatment Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 178}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-08', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-02-08', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Embryo implantation rate', 'timeFrame': '12 days after embryo transfer', 'description': 'defined as serum β-hCG ≥ 50 IU/L on day 12 after embryo transfer'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': '28 days after embryo transfer', 'description': 'confirmed by the presence of at least one intrauterine gestational sac on transvaginal ultrasound'}, {'measure': 'Generalized Anxiety Disorder 7-item scale', 'timeFrame': 'Baseline and 4 weeks after embryo transfer', 'description': '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).'}, {'measure': 'Patient Health Questionnaire-9 Score', 'timeFrame': 'Baseline and 4 weeks after embryo transfer', 'description': '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).'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'Baseline and 4 weeks after embryo transfer', 'description': '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).'}, {'measure': 'Change in objective sleep parameters measured by actigraphy', 'timeFrame': 'Baseline and 4 weeks after embryo transfer', 'description': '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.'}, {'measure': 'serum cortisol levels', 'timeFrame': 'Fasting morning venous blood samples are collected at 2 days (baseline) and 12 days after embryo transfer for analysis.', 'description': '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'}, {'measure': 'Serum serotonin (5-HT) levels', 'timeFrame': 'Fasting morning venous blood samples are collected at 2 days (baseline) and 12 days after embryo transfer for analysis.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Adverse Pregnancy Outcomes', 'timeFrame': 'From embryo transfer up to 12 weeks of gestation', 'description': 'Includes ectopic pregnancy, molar pregnancy, threatened abortion, embryonic/fetal demise, and other abnormal pregnancy conditions occurring during the study period. All outcomes will be confirmed by clinical assessment and ultrasound.'}, {'measure': 'Local discomfort at auricular acupressure sites assessed by Visual Analogue Scale (VAS)', 'timeFrame': 'From the start of intervention up to 4 weeks', 'description': 'Discomfort level at the site of auricular acupressure patches is assessed using a 100-mm Visual Analogue Scale. Participants mark a point on the line between 0 mm ("no discomfort at all") and 100 mm ("the worst discomfort imaginable"). Higher scores indicate worse local tolerance.'}, {'measure': 'Incidence of local skin reactions related to auricular acupressure', 'timeFrame': 'From the start of intervention up to 4 weeks', 'description': 'Includes ulceration, rash, pruritus, or other dermatological adverse events at the site of auricular acupressure patch application. Assessed by visual inspection and participant report.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Female', 'Anxiety', 'Assisted Reproductive Techniques', 'Dyssomnias', 'Depression']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\nDoes 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.\n\nParticipants will be randomly assigned to either the control group or the intervention group.\n\nIn the control group, receive standard luteal phase support medication (e.g., progesterone injections or oral dydrogesterone) for 4 weeks post-embryo transfer.\n\nIn 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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': '1.Diagnostic Criteria for Infertility\n\nThe 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:\n\n1. Be a woman of reproductive age, between 20 and 45 years old;\n2. Have failed to achieve a clinical pregnancy after ≥12 months of regular, unprotected intercourse (or ≥6 months for women aged ≥35).\n\nFurthermore, the indication for IVF-ET must be met by satisfying at least one of the following conditions:\n\n1. Ovulatory factor infertility (e.g., hypothalamic amenorrhea or menstrual disorders, pituitary amenorrhea or menstrual disorders, ovarian amenorrhea or menstrual disorders, other endocrine disorders);\n2. Pelvic factor infertility (e.g., congenital anomalies of the reproductive system, cervical factors, uterine disorders, tubal and/or peritoneal factors, endometriosis);\n3. Male factor infertility (e.g., azoospermia, oligospermia, asthenospermia, teratospermia, isolated abnormal seminal plasma);\n4. Unexplained infertility.\n\n2\\. Diagnostic Criteria for Anxiety State\n\nDiagnosis is based on the diagnostic criteria for anxiety disorders as outlined in the \\*Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)\\* and the \\*International Classification of Diseases, Eleventh Revision (ICD-11)\\*. Eligible patients must meet the following criteria:\n\n1. Score ≥5 on the self-administered Generalized Anxiety Disorder 7-item (GAD-7) scale;\n2. Exhibit significant anxiety symptoms: excessive worry not confined to specific circumstances, or disproportionate worry about various aspects of life;\n3. Experience associated symptoms, such as: muscle tension or restlessness; symptoms of autonomic hyperactivity (e.g., frequent gastrointestinal symptoms like nausea or abdominal discomfort, palpitations, sweating, trembling, dry mouth); subjective feelings of tension, restlessness, difficulty concentrating, or irritability;\n4. Symptoms persist for at least one month and are present most of the time;\n5. The symptoms are not better explained by another mental disorder, are not attributable to the physiological effects of a substance or medication (or its withdrawal), and are not a manifestation of another medical condition;\n6. The symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.\n\n3 Diagnostic Criteria for Insomnia Disorder Diagnosis is based on the diagnostic criteria for insomnia disorder as outlined in the \\*Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and the International Classification of Diseases, Eleventh Revision (ICD-11) 3. Eligible patients must meet the following criteria:\n\n1. Score ≥8 on the self-administered Pittsburgh Sleep Quality Index (PSQI);\n2. Report dissatisfaction with sleep quantity or quality, accompanied by one or more of the following symptoms: ① Difficulty initiating sleep (sleep latency \\>30 minutes); ② Difficulty maintaining sleep, characterized by frequent awakenings or difficulty returning to sleep after awakenings (wake after sleep onset \\>30 minutes); ③ Early morning awakening (waking \\>30 minutes earlier than desired) with inability to return to sleep;\n3. The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning;\n4. The sleep difficulty occurs at least three nights per week and has been present for at least one month;\n5. The insomnia is not better explained by and does not occur exclusively during the course of another sleep-wake disorder, mental disorder, or medical condition, and is not attributable to the physiological effects of a substance.\n\nInclusion Criteria:\n\n* (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.\n\nExclusion Criteria:\n\n* (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.'}, 'identificationModule': {'nctId': 'NCT07409792', 'briefTitle': 'Multifaceted Benefits of Auricular Point Sticking for IVF Patients: Psychological Well-being, Sleep, and Treatment Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University'}, 'officialTitle': 'The Synergistic Ameliorative Effects of Auricular Point Sticking Therapy on the Psychological Well-being, Sleep Quality, and Pregnancy Outcomes of IVF Patients', 'orgStudyIdInfo': {'id': '2025KLL180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Artificial Cycle Therapy', 'description': '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.', 'interventionNames': ['Drug: Conventional Artificial Cycle Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional artificial cycle therapy will be supplemented with auricular point sticking therapy', 'description': '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:\n\nUnilateral 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.', 'interventionNames': ['Other: auricular point sticking therapy', 'Drug: Conventional Artificial Cycle Therapy']}], 'interventions': [{'name': 'auricular point sticking therapy', 'type': 'OTHER', 'description': '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:\n\nUnilateral 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.', 'armGroupLabels': ['Conventional artificial cycle therapy will be supplemented with auricular point sticking therapy']}, {'name': 'Conventional Artificial Cycle Therapy', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Conventional Artificial Cycle Therapy', 'Conventional artificial cycle therapy will be supplemented with auricular point sticking therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310007', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Hangzhou Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Jing Ma', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gynecologist', 'investigatorFullName': 'Ying Zhu', 'investigatorAffiliation': 'Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University'}}}}