An interventional study of auricular point sticking therapy and Conventional Artificial Cycle Therapy in Infertility, Female, Anxiety and Assisted Reproductive Techniques, sponsored by Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University. Enrolling by invitation at 1 site in China. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University · Not applicable, Interventional, and Treatment
Among 58 studies in Infertility, Female with a site in China — 18 open to participants now, 20 under way, 1 of them phase 3. Infertility, Female · China.
Among the 58 studies in Infertility, Female with a site in China, this one is the 26th largest by planned enrollment of the 51 interventional ones that give a count, is one of 4 that started in 2026, is one of 32 with no phase, reaches primary completion later than 16 of the 19 other live ones, and was the 56th registered.
552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.
Browse Infertility, Female studies →18 of the 58 studies in Infertility, Female with a site in China are open now. Recruiting first, the newest first:
Shanghai 6th People's Hospital · Sites in China
Shandong University of Traditional Chinese Medicine · Sites in China
Tang-Du Hospital · Sites in China
Suzhou Centergene Pharmaceuticals Co.,Ltd. · Sites in China
Peking University Third Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 91 Infertility, Female studies recruiting now, 10 (11%) set no upper age limit and 81 (89%) stop at 75 or younger; 9 take children under 18; 30 take healthy volunteers.
This study: 20 Years to 45 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
58 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 1 · Phase 3 6 · Phase 4 4
First in 2014; this study’s year is marked. 4 started in 2026.
This study's planned enrollment of 178 is above the median of 100 across 378 interventional studies indexed under Infertility, Female.
Median enrollment 178 across the 51 interventional studies, 2,569 across the 7 observational. Of the 19 that completed or were terminated, 3 (16%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 58 have an industry lead sponsor. The 10 most frequent:
Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University has 1 study filed under Infertility, Female — fewer than ten, so there is no comparison to draw.
4 of the studies in Infertility, Female with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06644794Phase 3Shandong University of Traditional Chinese MedicineProgesterone-modified Natural Cycle for FET | 2027-09-10 |
| NCT06775093Peking University Third HospitalEffects of GLP-1RAs on Reproductive Outcomes in PCOS and Obesity | 2026-12-31 |
| NCT06020924Wenwen WangThe Effects of Uterine Fibroids on Pregnancy in Women | 2026-12-31 |
| NCT07409792Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical UniversityMultifaceted Benefits of Auricular Point Sticking for IVF Patients: Psychological Well-being, Sleep, and Treatment Outcomes | 2027-01-31 |
Among the 58 studies in Infertility, Female with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Furthermore, the indication for IVF-ET must be met by satisfying at least one of the following conditions:
2. Diagnostic Criteria for Anxiety State
Diagnosis is based on the diagnostic criteria for anxiety disorders as outlined in the *, Fifth Edition (DSM-5)* and the *International Classification of Diseases, Eleventh Revision (ICD-11)*. Eligible patients must meet the following criteria:
3 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:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Clinical pregnancy rate
confirmed by the presence of at least one intrauterine gestational sac on transvaginal ultrasound
Time frame: 28 days after embryo transfer
Adverse Pregnancy Outcomes
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.
Time frame: From embryo transfer up to 12 weeks of gestation
Embryo implantation rate
defined as serum β-hCG ≥ 50 IU/L on day 12 after embryo transfer
Time frame: 12 days after embryo transfer
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.
Time frame: Fasting morning venous blood samples are collected at 2 days (baseline) and 12 days after embryo transfer for analysis.
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
Time frame: Fasting morning venous blood samples are collected at 2 days (baseline) and 12 days after embryo transfer for analysis.
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).
Time frame: 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.
Time frame: 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).
Time frame: Baseline and 4 weeks 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).
Time frame: Baseline and 4 weeks after embryo transfer
Local discomfort at auricular acupressure sites assessed by Visual Analogue Scale (VAS)
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.
Time frame: From the start of intervention up to 4 weeks
Incidence of local skin reactions related to auricular acupressure
Includes ulceration, rash, pruritus, or other dermatological adverse events at the site of auricular acupressure patch application. Assessed by visual inspection and participant report.
Time frame: From the start of intervention up to 4 weeks
Started Feb 2026 (actual). Primary completion is estimated for Jan 2027, 11 months after the start.
Of 141 non-industry interventional studies with no phase under Infertility, Female, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 11 months is below that.
Counting every sponsor, half of 155 studies reached it within 23 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University