Infertility, FemaleNCT07409792
Multifaceted Benefits of Auricular Point Sticking for IVF Patients: Psychological Well-being, Sleep, and Treatment Outcomes
A study testing auricular point sticking therapy and Conventional Artificial Cycle Therapy in people with Infertility, Female and Anxiety, run by Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Infertility, Female, Anxiety, Assisted Reproductive Techniques
- What is being tested?
- auricular point sticking therapy and Conventional Artificial Cycle Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Hangzhou Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, 310007
About this study
Official title: The Synergistic Ameliorative Effects of Auricular Point Sticking Therapy on the Psychological Well-being, Sleep Quality, and Pregnancy Outcomes of IVF Patients
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:
Read more
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).
- Being tested
- auricular point sticking therapy, Conventional Artificial Cycle Therapy
- Medical subject headings
- Infertility, Female, Anxiety Disorders, Dyssomnias, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular point sticking therapyOther
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 TherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: auricular point sticking therapy; Drug: Conventional Artificial Cycle Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
confirmed by the presence of at least one intrauterine gestational sac on transvaginal ultrasound
Measured: 28 days after embryo transfer
Secondary outcomes (10)
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From the start of intervention up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Feb 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Zhu, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University
- Investigators
- Jing Ma, Study director, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409792
- Sponsor's protocol ID
- 2025KLL180
- Status last verified
- Jun 2026
- First submitted
- 29 Jan 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Synergistic Ameliorative Effects of Auricular Point Sticking Therapy on the Psychological Well-being, Sleep Quality, and Pregnancy Outcomes of IVF Patients
- ClinicalTrials.gov ID
- NCT07409792
- Acronym / sponsor ID
- 2025KLL180
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Artificial Cycle Therapy | Active comparator | Drug: Conventional Artificial Cycle TherapyPatients 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 will be supplemented with auricular point sticking therapy | Experimental | Other: auricular point sticking therapy, Drug: Conventional Artificial Cycle TherapyPatients 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auricular point sticking therapyPatients 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 | Conventional artificial cycle therapy will be supplemented with auricular point sticking therapy |
| Conventional Artificial Cycle TherapyPatients 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 |
Primary outcome
Clinical pregnancy rate
Time frame: 28 days after embryo transfer
confirmed by the presence of at least one intrauterine gestational sac on transvaginal ultrasound
10 secondary outcomes
Adverse Pregnancy Outcomes
Time frame: From embryo transfer up to 12 weeks of gestation
Embryo implantation rate
Time frame: 12 days after embryo transfer
Serum serotonin (5-HT) levels
Time frame: Fasting morning venous blood samples are collected at 2 days (baseline) and 12 days after embryo transfer for analysis.
serum cortisol levels
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
Time frame: Baseline and 4 weeks after embryo transfer
Change in objective sleep parameters measured by actigraphy
Time frame: Baseline and 4 weeks after embryo transfer
Patient Health Questionnaire-9 Score
Time frame: Baseline and 4 weeks after embryo transfer
Generalized Anxiety Disorder 7-item scale
Time frame: Baseline and 4 weeks after embryo transfer
Local discomfort at auricular acupressure sites assessed by Visual Analogue Scale (VAS)
Time frame: From the start of intervention up to 4 weeks
Incidence of local skin reactions related to auricular acupressure
Time frame: From the start of intervention up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Ma study director
Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auricular point sticking therapy and Conventional Artificial Cycle Therapy in people with Infertility, Female and Anxiety, run by Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 28 days after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.