Diminished Ovarian ReserveTN-DORNCT05277948
Effect of Thumbtack Needle (TN) on Ovarian Reserve Function of Women With Diminished Ovarian Reserve (DOR)
A study testing active TN and ETN treatment in people with Diminished Ovarian Reserve, run by Dongmei Huang at 1 site in China.
Trial summary
Using a multi-center, large sample, randomized, patient-assessor blinded, sham-controlled clinical trial to evaluate the effect of thumbtack needle (TN) on ovarian function of patients with diminished ovarian reserve (DOR). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve
- What is being tested?
- active TN and ETN treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2021to 6 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with age between 18 and 40 years;
- Low ovarian reserve: AMH<1.1ng/ml; or AFC<7; or 10 U/L<FSH<25U/L or FSH/LH>3.6; or has a history of poor ovarian response, that is, in the last controlled hyperstimulation cycle, the number of retrieved oocytes<3. Any 2 of the above 4 conditions are met.
- Sign informed consent voluntarily.
Who cannot join
- Patient's chromosome is abnormal.
- Patients with previous ovarian surgery because of such as ovarian teratoma or chocolate cyst and so on.
- Patients with uncorrected endocrine disease, such as: Simple hyperthyroidism or hypothyroidism, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, etc.
- Patients with definitively diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, Sjogren's syndrome, Hashimoto's thyroiditis.
- Patients with a history of cancer and has received radiotherapy or chemotherapy.
- Patients had the treatment of acupuncture or thumbtack needle in recent 3 months.
- Patients who take Chinese medicine decoction or granule during the treatment;
- Patients unwilling to sign the informed consent of this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Effect of Thumbtack Needle (TN) on Ovarian Reserve Function of Women With Diminished Ovarian Reserve (DOR): A Randomized Controlled Clinical Trial
Using a multi-center, large sample, randomized, patient-assessor blinded, sham-controlled clinical trial to evaluate the effect of thumbtack needle (TN) on ovarian function of patients with diminished ovarian reserve (DOR).
Read the detailed description
Diminished ovarian reserve (DOR) is the precursor state of ovarian failure, and can cause the decline of women's reproductive function. Some studies have demonstrated that acupuncture can improve ovarian reserve function. Thumbtack needle (TN), as a kind of acupuncture, is a form of long-term indwelling intradermal needle therapy. TN has been found effective in treating DOR in our clinic. In this study, a multi-center, large sample, randomized, patient-assessor blinded, sham-controlled clinical trial was used to evaluate the effect of TN on ovarian reserve function of patients with diminished ovarian reserve (DOR).
First, patients will be recruited according to the inclusion criteria and exclusion criteria.
Second, baseline measurements (including ovarian reserve function, blood biochemical index, scores from the self-rating anxiety and depression scale, quality of life, sleep status) will be taken.
Third, each patient will receive the treatment of TN or sham TN for a total of 2 menstrual cycles.
Fourth, the above baseline measurements will be taken again as soon as the treatment is finished and outcome measures will be recorded after the treatment.
Last, Natural pregnancy outcomes includes natural pregnancy rate (including biochemical pregnancy rate, clinical pregnancy rate) and miscarriage rate during the treatment period and within 6 months after treatment completion will be followed up. Pregnancy outcome Includes number of oocytes retrieved, fertilization rate, embryo formation rate, blastocyst formation rate, biochemical pregnancy rate, clinical pregnancy rate and miscarriage rate during IVF-ET within 6 months after treatment completion will also be followed up.
- Conditions
- Diminished Ovarian Reserve
- Being tested
- active TN and ETN treatment, sham TN and sham ETN treatment
- Keywords
- diminished ovarian reserve, thumbtack needle, ovarian reserve function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active TN and ETN treatmentOther
The following 12 acupoints including conception vessel (CV) 4, CV3, bilateral ovary acupoints, bilateral spleen (SP) 6, bilateral stomach (ST) 36, bilateral bladder (BL) 23 and bilateral EX-B7 will be used. Eight acupoints of CV4, CV3, SP6, ST36 and BL23 will be treated by disposable sterile thumbtack needle (TN) for single use (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM2-6YDL), and four acupoints of bilateral ovary acupoints and bilateral EX-B7 will be treated by disposable sterile electro-thumbtack needle (ETN) (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM3-ZY) with pulsed electrical stimulation.
The patients will receive a treatment of 2 menstrual cycles.
sham TN and sham ETN treatmentOther
The acupoints used in the control group are the same as those in the treatment group. Eight points of CV4, CV3, SP6, ST36 and BL23 will be treated by the sterile sham thumbtack needle (TN) for single use (Hangzhou Zhuomai Medical Technology Co., LTD.), and four points of bilateral ovary acupoints and bilateral EX-B7 will be treated by disposable sterile sham electro-thumbtack needle (ETN) (Hangzhou Zhuomai Medical Technology Co., LTD.) with sham pulsed electrical stimulation.
The sham TN and ETN used in this group are identical in appearance, shape, and color to the active TN and ETN but lack the needle body, thus lacking the needle-penetrating effect. The stimulation method and frequency for the sham ETN are the same as those of the ETN group. The only difference is that the electrode pads used in the sham ETN group are specially designed as insulated controls.
The patients will receive a treatment of 2 menstrual cycles
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Active comparator | Active thumbtack needle (TN) and electro-thumbtack needle (ETN) will be used in the treatment group Receives: Other: active TN and ETN treatment |
| control group | Sham comparator | Sham thumbtack needle (TN) and sham electro-thumbtack needle (ETN) will be used in the control group Receives: Other: sham TN and sham ETN treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the change of serum AMH level
Assessing patients' serum level of AMH in ng/ml at baseline (0 week) and immediately (up to 4 weeks) after treatment completion.
Measured: 0 week and up to 4 weeks after treatment completion
Evaluating the change of the ovarian antral follicle count (AFC)
Counting the number of ovarian antral follicle count (AFC) on the second day of menstruation at baseline (0 week) and immediately (up to 4 weeks) after treatment completion.
Measured: 0 week and up to 4 weeks after treatment completion
Secondary outcomes (20)
Evaluating the serum levels of sex hormones
Evaluating the serum levels of sex hormones (FSH, LH, E2, P, T, and PRL) on the second day of menstruation at baseline and immediately (up to 4 weeks) after treatment completion.
Measured: 0 week and up to 4 weeks after treatment completion
Natural pregnancy outcomes include natural pregnancy rate and miscarriage rate
Natural pregnancy outcomes include natural pregnancy rate (including biochemical pregnancy rate, and clinical pregnancy rate) and miscarriage rate during the treatment period and within 6 months after treatment completion.
Measured: 0 week and within 6 months after treatment completion
Pregnancy outcomes of IVF-ET within 6 Months after Treatment Completion
Pregnancy outcomes Include number of oocytes retrieved, fertilization rate, embryo formation rate, blastocyst formation rate, biochemical pregnancy rate, clinical pregnancy rate, and miscarriage rate during IVF-ET within 6 months after treatment completion.
Measured: 0 week and within 6 months after treatment completion
Observing the level of transforming growth factor β (TGF β) in follicular fluid
Observing follicular fluid level of transforming growth factor β (TGF β) when patients undergoing IVF/ICSI
-ET after the treatment.
Measured: within 6 months after treatment completion
Observing the level of tumor necrosis factor-α (TNF-α) in follicular fluid
Observing follicular fluid level of TNF-α when patients undergoing IVF/ICSI
-ET after the treatment.
Measured: within 6 months after treatment completion
Observing the level of reactive oxygen species (ROS) in follicular fluid
Observing follicular fluid level of ROS when patients undergoing IVF/ICSI
-ET after the treatment.
Measured: within 6 months after treatment completion
Observing the level of superoxide dismutase (SOD) in follicular fluid
Observing follicular fluid level of SOD when patients undergoing IVF/ICSI
-ET after the treatment.
Measured: within 6 months after treatment completion
Blood corticotropin-releasing hormone (CRH) examination
Observing the level of blood corticotropin-releasing hormone (CRH) at baseline and immediately after treatment
Measured: 0 week and up to 4 weeks after treatment completion
Blood norepinephrine index examination
Observing the level of blood norepinephrine at baseline and immediately after treatment
Measured: 0 week and up to 4 weeks after treatment completion
Blood 5-hydroxytryptamine (5-HT) index examination
Observing the level of blood 5-hydroxytryptamine (5-HT) at baseline and immediately after treatment
Measured: 0 week and up to 4 weeks after treatment completion
Blood beta-aminobutyric acid (GABA) examination
Observing the level of blood beta-aminobutyric acid (GABA) at baseline and immediately after treatment
Measured: 0 week and up to 4 weeks after treatment completion
Blood dopamine (DA) examination
Observing the level of blood dopamine (DA) at baseline and immediately after treatment
Measured: 0 week and up to 4 weeks after treatment completion
Blood neuro-endorphin (β-ET) examination
Observing the level of blood neuro-endorphin (β-ET) at baseline and immediately after treatment
Measured: 0 week and up to 4 weeks after treatment completion
Evaluation of anxiety status
Anxiety status will be assessed using Zung anxiety self-rating scale (Zung-SAS) at baseline and immediately after treatment.
Measured: 0 week and up to 4 weeks after treatment completion
Evaluation of depression status
Depression status will be assessed using Zung depression self-rating scale (Zung-SDS) at baseline and immediately after treatment.
Measured: 0 week and up to 4 weeks after treatment completion
Evaluation of quality of life
Quality of life will be assessed by SF-36 at baseline and immediately after treatment..
Measured: 0 week and up to 4 weeks after treatment completion
Evaluation of sleep state
Sleep status will be evaluated using Pittsburgh sleep quality index (PSQI) at baseline and immediately after treatment.
Measured: 0 week and up to 4 weeks after treatment completion
Untargeted metabolomics levels in serum
Untargeted metabolomics levels in patient serum before and after treatment.
Measured: 0 week and up to 4 weeks after treatment completion
Untargeted metabolomics levels in follicular fluid
Observing untargeted metabolomics levels in follicular fluid collected from patients undergoing IVF/ICSI-ET cycle after treatment completion
Measured: During IVF-ET within 6 months after study completion
Proteomic analysis of granulosa cells
Proteomic analysis of granulosa cells collected during IVF-ET cycles after treatment.
Measured: During IVF-ET within 6 months after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start18 Oct 2021
- Primary completion28 Nov 2025
- Study completion6 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian ReserveStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongmei Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dongmei Huang, Huazhong University of Science and Technology
- Investigators
- Hanwang Zhang, Principal investigator, Huazhong University of Science Tech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277948
- Sponsor's protocol ID
- Effect of TN on DOR
- Acronym
- TN-DOR
- Status last verified
- Feb 2026
- First submitted
- 22 Dec 2021
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we use the Clinical Trial Management Public Platform to manage and share our date
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thumbtack Needle (TN) on Ovarian Reserve Function of Women With Diminished Ovarian Reserve (DOR): A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05277948
- Acronym / sponsor ID
- TN-DOR / Effect of TN on DOR
- Conditions
- Diminished Ovarian Reserve
- Keywords
- diminished ovarian reserve, thumbtack needle, ovarian reserve function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Dongmei HuangUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 6 Dec 2025 (actual)
- First posted
- 14 Mar 2022 (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.
Using a multi-center, large sample, randomized, patient-assessor blinded, sham-controlled clinical trial to evaluate the effect of thumbtack needle (TN) on ovarian function of patients with diminished ovarian reserve (DOR).
Detailed description
Diminished ovarian reserve (DOR) is the precursor state of ovarian failure, and can cause the decline of women's reproductive function. Some studies have demonstrated that acupuncture can improve ovarian reserve function. Thumbtack needle (TN), as a kind of acupuncture, is a form of long-term indwelling intradermal needle therapy. TN has been found effective in treating DOR in our clinic. In this study, a multi-center, large sample, randomized, patient-assessor blinded, sham-controlled clinical trial was used to evaluate the effect of TN on ovarian reserve function of patients with diminished ovarian reserve (DOR).
First, patients will be recruited according to the inclusion criteria and exclusion criteria.
Second, baseline measurements (including ovarian reserve function, blood biochemical index, scores from the self-rating anxiety and depression scale, quality of life, sleep status) will be taken.
Third, each patient will receive the treatment of TN or sham TN for a total of 2 menstrual cycles.
Fourth, the above baseline measurements will be taken again as soon as the treatment is finished and outcome measures will be recorded after the treatment.
Last, Natural pregnancy outcomes includes natural pregnancy rate (including biochemical pregnancy rate, clinical pregnancy rate) and miscarriage rate during the treatment period and within 6 months after treatment completion will be followed up. Pregnancy outcome Includes number of oocytes retrieved, fertilization rate, embryo formation rate, blastocyst formation rate, biochemical pregnancy rate, clinical pregnancy rate and miscarriage rate during IVF-ET within 6 months after treatment completion will also be followed up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Active comparator | Other: active TN and ETN treatmentActive thumbtack needle (TN) and electro-thumbtack needle (ETN) will be used in the treatment group |
| control group | Sham comparator | Other: sham TN and sham ETN treatmentSham thumbtack needle (TN) and sham electro-thumbtack needle (ETN) will be used in the control group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with age between 18 and 40 years;
- Low ovarian reserve: AMH<1.1ng/ml; or AFC<7; or 10 U/L<FSH<25U/L or FSH/LH>3.6; or has a history of poor ovarian response, that is, in the last controlled hyperstimulation cycle, the number of retrieved oocytes<3. Any 2 of the above 4 conditions are met.
- Sign informed consent voluntarily.
Key exclusion criteria (8 listed)
- Patient's chromosome is abnormal.
- Patients with previous ovarian surgery because of such as ovarian teratoma or chocolate cyst and so on.
- Patients with uncorrected endocrine disease, such as: Simple hyperthyroidism or hypothyroidism, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, etc.
- Patients with definitively diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, Sjogren's syndrome, Hashimoto's thyroiditis.
- Patients with a history of cancer and has received radiotherapy or chemotherapy.
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 |
|---|---|---|
| active TN and ETN treatmentThe following 12 acupoints including conception vessel (CV) 4, CV3, bilateral ovary acupoints, bilateral spleen (SP) 6, bilateral stomach (ST) 36, bilateral bladder (BL) 23 and bilateral EX-B7 will be used. Eight acupoints of CV4, CV3, SP6, ST36 and BL23 will be treated by disposable sterile thumbtack needle (TN) for single use (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM2-6YDL), and four acupoints of bilateral ovary acupoints and bilateral EX-B7 will be treated by disposable sterile electro-thumbtack needle (ETN) (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM3-ZY) with pulsed electrical stimulation. The patients will receive a treatment of 2 menstrual cycles. | Other | treatment group |
| sham TN and sham ETN treatmentThe acupoints used in the control group are the same as those in the treatment group. Eight points of CV4, CV3, SP6, ST36 and BL23 will be treated by the sterile sham thumbtack needle (TN) for single use (Hangzhou Zhuomai Medical Technology Co., LTD.), and four points of bilateral ovary acupoints and bilateral EX-B7 will be treated by disposable sterile sham electro-thumbtack needle (ETN) (Hangzhou Zhuomai Medical Technology Co., LTD.) with sham pulsed electrical stimulation. The sham TN and ETN used in this group are identical in appearance, shape, and color to the active TN and ETN but lack the needle body, thus lacking the needle-penetrating effect. The stimulation method and frequency for the sham ETN are the same as those of the ETN group. The only difference is that the electrode pads used in the sham ETN group are specially designed as insulated controls. The patients will receive a treatment of 2 menstrual cycles | Other | control group |
Primary outcome
Evaluating the change of serum AMH level
Time frame: 0 week and up to 4 weeks after treatment completion
Assessing patients' serum level of AMH in ng/ml at baseline (0 week) and immediately (up to 4 weeks) after treatment completion.
Evaluating the change of the ovarian antral follicle count (AFC)
Time frame: 0 week and up to 4 weeks after treatment completion
Counting the number of ovarian antral follicle count (AFC) on the second day of menstruation at baseline (0 week) and immediately (up to 4 weeks) after treatment completion.
20 secondary outcomes
Evaluating the serum levels of sex hormones
Time frame: 0 week and up to 4 weeks after treatment completion
Natural pregnancy outcomes include natural pregnancy rate and miscarriage rate
Time frame: 0 week and within 6 months after treatment completion
Pregnancy outcomes of IVF-ET within 6 Months after Treatment Completion
Time frame: 0 week and within 6 months after treatment completion
Observing the level of transforming growth factor β (TGF β) in follicular fluid
Time frame: within 6 months after treatment completion
Observing the level of tumor necrosis factor-α (TNF-α) in follicular fluid
Time frame: within 6 months after treatment completion
Observing the level of reactive oxygen species (ROS) in follicular fluid
Time frame: within 6 months after treatment completion
Observing the level of superoxide dismutase (SOD) in follicular fluid
Time frame: within 6 months after treatment completion
Blood corticotropin-releasing hormone (CRH) examination
Time frame: 0 week and up to 4 weeks after treatment completion
Blood norepinephrine index examination
Time frame: 0 week and up to 4 weeks after treatment completion
Blood 5-hydroxytryptamine (5-HT) index examination
Time frame: 0 week and up to 4 weeks after treatment completion
Blood beta-aminobutyric acid (GABA) examination
Time frame: 0 week and up to 4 weeks after treatment completion
Blood dopamine (DA) examination
Time frame: 0 week and up to 4 weeks after treatment completion
Blood neuro-endorphin (β-ET) examination
Time frame: 0 week and up to 4 weeks after treatment completion
Evaluation of anxiety status
Time frame: 0 week and up to 4 weeks after treatment completion
Evaluation of depression status
Time frame: 0 week and up to 4 weeks after treatment completion
Evaluation of quality of life
Time frame: 0 week and up to 4 weeks after treatment completion
Evaluation of sleep state
Time frame: 0 week and up to 4 weeks after treatment completion
Untargeted metabolomics levels in serum
Time frame: 0 week and up to 4 weeks after treatment completion
Untargeted metabolomics levels in follicular fluid
Time frame: During IVF-ET within 6 months after study completion
Proteomic analysis of granulosa cells
Time frame: During IVF-ET within 6 months after study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. we use the Clinical Trial Management Public Platform to manage and share our date
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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. This study is not recruiting at the moment.
Hanwang Zhang principal investigator
Huazhong University of Science Tech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active TN and ETN treatment in people with Diminished Ovarian Reserve, run by Dongmei Huang 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 1 Sep 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluating the change of serum AMH level (time frame: 0 week and up to 4 weeks after treatment completion). The study lists 2 primary outcomes in all. 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 1 Sep 2026.