Diminished Ovarian Reserve (DOR)NCT07142187
The Clinical Trial of Electro-thumbtack Needle on Live Birth Rate in Patients With Ovarian Reserve Dysfunction (DOR)
A study testing electro-thumbtack needle in people with Diminished Ovarian Reserve (DOR), run by Huazhong University of Science and Technology.
Trial summary
This study will include 246 patients with ovarian reserve dysfunction (DOR), who will be randomly divided into a treatment group and a control group, with 123 patients in each group. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve (DOR)
- What is being tested?
- electro-thumbtack needle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 30 Oct 2029
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The age range is 18-40 years old;
- Meets the diagnostic criteria for DOR as follows: ① AMH<1.1 ng/ml; ② 10 U/L < FSH < 25U/L or FSH/LH > 3.6; ③ The total number of follicles (AFC) in both basal sinuses is less than 7. If any two of the above criteria (①②③) are met, it can be diagnosed as DOR.
- At least one side of the patient's fallopian tube is unobstructed;
- The semen routine examination of the patient's spouse is normal;
- Voluntarily sign the informed consent form.
Who cannot join
- Chromosomal or genetic abnormalities in either the female or male partner;
- Women with blocked fallopian tubes on both sides;
- Have a history of ovarian surgery, such as ovarian teratoma or ovarian chocolate cyst surgery;
- The female party suffers from uncorrected endocrine disorders such as simple hyperthyroidism or hypothyroidism, hyperprolactinemia, and pancreatic islet dysfunction;
- Hormone resistance, diabetes, adrenal diseases, etc;
- The woman has a clearly diagnosed autoimmune disease such as systemic lupus erythematosus, rheumatoid arthritis;
Show all 14Show fewer
- Antiphospholipid syndrome, Sjogren's syndrome, Hashimoto's thyroiditis, etc;
- The female or male partner has a history of malignant tumors and has received treatment with radiotherapy and chemotherapy;
- The woman has received acupuncture and moxibustion or press acupuncture treatment in recent 3 months;
- Those who take traditional Chinese medicine decoctions or granules during treatment;
- Men with abnormal semen examination;
- Clear diagnosis of moderate or severe adenomyosis;
- Clearly diagnose uterine fibroids with a diameter greater than 5cm;
- I do not agree to sign the informed consent form for this study.
About this study
Official title: The Effect of Electro-thumbtack Needle on Live Birth Rate in Patients With Ovarian Reserve Dysfunction (DOR): a Multicenter Randomized Controlled Clinical Trial
This study will include 246 patients with ovarian reserve dysfunction (DOR), who will be randomly divided into a treatment group and a control group, with 123 patients in each group. The treatment group will receive electro-thumbtack needle treatment, while the control group will receive placebo electro-thumbtack needle treatment. Both groups will receive a treatment course of 3 menstrual cycles. This study evaluates the effect of electrocautery on the live birth rate of patients with DOR.
- Conditions
- Diminished Ovarian Reserve (DOR)
- Being tested
- electro-thumbtack needle, placebo electro-thumbtack needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electro-thumbtack needleOther
The treatment acupoints include bilateral ovarian acupoints, Guan Yuan (CV4), bilateral Shen Shu (BL23), bilateral waist and eye acupoints (EX-B7), bilateral San Yin Jiao (SP6), and bilateral Zu San Li (ST36), totaling 11 acupoints. Among them, the bilateral ovarian acupoints and bilateral waist eye acupoints (EX-B7) were treated with electro-thumbtack needle. Other acupoints were treated with thumbtack needle.Choose a sparse and dense waveform, adjust the intensity to the maximum patient can tolerate, and stimulate for 30 minutes each time. After the stimulation is completed, remove the electrode patch and electroacupuncture device, and keep the electric needle at the acupoint for another 3 days.During the needle retention period, the electric needles at the bilateral ovarian acupoints and bilateral waist and eye acupoints were alternately stimulated once every other day using an electroacupuncture device for 30 minutes each time.
placebo electro-thumbtack needleOther
The control group selected acupoints that were the same as the treatment group. Bilateral ovarian acupoints and bilateral waist and eye acupoints are treated with placebo electro-thumbtack needle, while other acupoints are treated with placebo electro-thumbtack needle. The treatment methods for placebo electro-thumbtack needle and placebo thumbtack needle are the same as those for the treatment group.
| Study group | Role | What they receive |
|---|---|---|
| electro-thumbtack needle group | Experimental | Electro-thumbtack needle is a sterile needle with a special conductive chip that can conduct electricity. Electro-thumbtack needle enhances the stimulation effect on acupoints by introducing pulsed microcurrents, and is a long-lasting needle retention therapy with stronger stimulation effect than ordinary acupressure. Receives: Other: electro-thumbtack needle |
| Placebo group | Placebo comparator | Placebo electro-thumbtack needle use insulated soft silk threads instead of needle bodies, making their appearance, shape, and color no different from real electro-thumbtack needle, but without needle like effects; Placebo electro-thumbtack needle also do not have the conductivity of true electric needles (silk threads are insulated); The placebo conductive patch used in the control group, although having the same appearance as the treatment group, is a specially insulated control substance. Therefore, even if the pulse generator is turned on and adjusted to medium intensity, the patient still receives zero current stimulation intensity. Receives: Other: placebo electro-thumbtack needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
The live birth rate is defined as the proportion of live births after 28 weeks of pregnancy, usually calculated by dividing the number of live birth cycles by the total number of patients and multiplying by 100%. This indicator is commonly used to evaluate the effectiveness of reproductive health centers or specific treatment methods, reflecting the ultimate outcome of successful pregnancy.
Measured: 3 months
Secondary outcomes (26)
Biochemical pregnancy rate
Biochemical pregnancy, also known as subclinical miscarriage or occult miscarriage, refers to the phenomenon where the embryo fails to successfully implant on the uterine wall in the early stages, leading to termination of pregnancy.The biochemical pregnancy rate is calculated by dividing the number of biochemical pregnancies by the total number of patients.
Measured: 3 months
clinical pregnancy rate
Clinical pregnancy refers to the presence of a gestational sac in the uterine cavity, as well as the appearance of fetal buds and primitive heartbeats, observed through ultrasound examination in the early stages of pregnancy. These signs indicate normal implantation and development of the embryo, confirming a normal intrauterine pregnancy.The clinical pregnancy rate is calculated by dividing the number of pregnancies by the total number of patients.
Measured: 3 months
Threatened miscarriage rate
Threatened miscarriage refers to symptoms such as vaginal bleeding and abdominal pain that occur before 28 weeks of pregnancy, but at this time the cervix is not open, the membranes are intact, there is no discharge of pregnancy material, and the size of the uterus matches the gestational age. The threatened miscarriage rate is calculated by dividing the number of threatened miscarriages by the total number of patients.
Measured: 3 months
abortion rate
The miscarriage rate is calculated by dividing the number of miscarriages by the total number of patients.
Measured: 3 months
Anti Mullerian hormone (AMH)
Anti Mullerian hormone (AMH) is a glycoprotein hormone secreted by follicular granulosa cells in the ovary. It is of great significance in evaluating women's ovarian reserve function and can be used to assess the number and quality of follicles in the ovaries. The concentration of AMH in serum will be measured.
Measured: 3 months
Antral Follicle Count (AFC)
Antral Follicle Count (AFC) refers to the count of antral follicles present in the ovary using ultrasound technology. Sinus follicles are small follicles with a diameter of approximately 2-9mm located in the ovary. These follicles are in the early developmental stage of the cycle and have a good correlation with women's ovarian reserve function
Measured: 3 months
follicle stimulating hormone（FSH）
The concentration of follicle stimulating hormone（FSH） in serum will be measured. The changes in FSH levels can reflect ovarian function and ovulation status, and are of great significance for the diagnosis and monitoring of various gynecological diseases.FSH was measured on the second day of menstruation.
Measured: 3 months
Luteinizing hormone (LH)
The concentration of Luteinizing hormone (LH) in serum will be measured. LH is a glycoprotein hormone secreted by pituitary cells, mainly acting on mature oocytes, which can induce ovulation and produce corpus luteum.LH is measured on the second day of menstruation.
Measured: 3 months
estradiol（E2）
The concentration of estradiol（E2） in serum will be measured.The level of estradiol is commonly used to assess the reproductive health status of women, which is measured on the second day of menstruation.
Measured: 3 months
Progesterone（P）
The concentration of Progesterone（P） in serum will be measured.Progesterone is an important progesterone mainly secreted by the corpus luteum of the ovary and also present in the adrenal cortex and placenta. Progesterone plays a crucial role in the female reproductive system, including maintaining normal menstrual cycles, promoting endometrial development, providing a suitable implantation environment for fertilized eggs, and maintaining pregnancy.
Measured: 3 months
Prolactin（PRL）
The concentration of Prolactin（PRL） in serum will be measured.Prolactin also affects female reproductive function, such as follicle development and ovulation process
Measured: 3 months
Testosterone（T）
The concentration of Testosterone（T） in serum will be measured.Testosterone is a steroid hormone mainly secreted by the testicles of males and ovaries of females
Measured: 3 months
ZungSelf-RatingAnxietyScale（Zung-SAS）
Zung SAS is mainly used to evaluate an individual's anxiety symptoms and their severity.The total score range of this scale is 20 to 80 points. After conversion, the score can be used as an indicator of anxiety level - usually multiplying the original score by 1.25 and converting it into a norm score. The higher the norm score, the more severe the individual's anxiety level.
Measured: 3 months
Zung Self-rating depression scale(Zung-SDS)
Zung SDS is mainly used to evaluate the severity and changes of individual depressive symptoms.Composed of 20 questions, the scores of each of the 20 items are added together to obtain a rough score. The standard score is equal to the integer part obtained by multiplying the coarse score by 1.25. The normal upper limit of the total gross score is 41 points, and the standard total score is 53 points.
Measured: 3 months
Short form-36（SF-36）
SF-36， The Medical Outcomes Study - Short Form, also known as the Health Survey Short Form, is a universal measurement scale developed from the Boston Health Study in the United States. This scale consists of 36 items and is evaluated.The score range of SF-36 scale is 0-100 points, where 100 points represents the best health status and 0 points represents the worst health status.
Measured: 3 months
Chinese Quality of Life Scale (CHQOL)
The Chinese Quality of Life Scale (CHQOL) is a new universal scale developed based on the concept of traditional Chinese medicine health, which is used for evaluation.Full score of 60, the higher the score, the higher the quality of life.
Measured: 3 months
Self Rating Sleep Scale (SRSS)
SRSS is a tool used to screen and evaluate individual sleep problems. It consists of 10 items, each rated on a 5-point scale, with higher scores indicating more severe sleep problems. The scoring criteria for the SRSS are as follows: 10 items are rated on a scale of 1-5, with a total score range of 10-50 points. The higher the score, the more severe the sleep problem.
Measured: 3 months
The Sleep Disorders Rating Scale (SDRS)
The Sleep Disorders Rating Scale (SDRS) is a tool used to assess an individual's sleep status over the past week.Each item has a maximum score of 3 points, and the total score can reach up to 21 points. The higher the score, the more severe the sleep disorder.
Measured: 3 months
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-assessment scale used to evaluate an individual's sleep quality over the past month.The total score range of the scale is 0-21 points, with higher scores indicating poorer sleep quality.
Measured: 3 months
corticotropin releasing hormone (CRH)
The concentration of CRH in serum will be measured.Corticotropin releasing hormone (CRH) is a forty one peptide hormone secreted by the hypothalamus. Its main function is to promote the synthesis and release of adrenocorticotropic hormone (ACTH) by the pituitary gland, thereby regulating the secretion of glucocorticoids by the adrenal cortex
Measured: 3 months
norepinephrine
The concentration of norepinephrine in serum will be measured.
Measured: 3 month
epinephrine
The concentration of epinephrine in serum will be measured.
Measured: 3 months
5-hydroxytryptamine (5-HT)
The concentration of 5-hydroxytryptamine (5-HT) in serum will be measured.
Measured: 3 months
gamma aminobutyric acid (GABA)
The concentration of gamma aminobutyric acid (GABA) in serum will be measured.
Measured: 3 months
dopamine (DA)
The concentration of dopamine (DA) in serum will be measured.
Measured: 3 months
beta endorphin (β - ET)
The concentration of beta endorphin (β - ET) in serum will be measured.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Oct 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian Reserve (DOR)Studies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongmei Huang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142187
- Sponsor's protocol ID
- TJ-IRB202508011
- Status last verified
- Aug 2025
- First submitted
- 6 Apr 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Electro-thumbtack Needle on Live Birth Rate in Patients With Ovarian Reserve Dysfunction (DOR): a Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07142187
- Acronym / sponsor ID
- TJ-IRB202508011
- Conditions
- Diminished Ovarian Reserve (DOR)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Oct 2029 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 26 Aug 2025 (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.
This study will include 246 patients with ovarian reserve dysfunction (DOR), who will be randomly divided into a treatment group and a control group, with 123 patients in each group. The treatment group will receive electro-thumbtack needle treatment, while the control group will receive placebo electro-thumbtack needle treatment. Both groups will receive a treatment course of 3 menstrual cycles. This study evaluates the effect of electrocautery on the live birth rate of patients with DOR.
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 |
|---|---|---|
| electro-thumbtack needle group | Experimental | Other: electro-thumbtack needleElectro-thumbtack needle is a sterile needle with a special conductive chip that can conduct electricity. Electro-thumbtack needle enhances the stimulation effect on acupoints by introducing pulsed microcurrents, and is a long-lasting needle retention therapy with stronger stimulation effect than ordinary acupressure. |
| Placebo group | Placebo comparator | Other: placebo electro-thumbtack needlePlacebo electro-thumbtack needle use insulated soft silk threads instead of needle bodies, making their appearance, shape, and color no different from real electro-thumbtack needle, but without needle like effects; Placebo electro-thumbtack needle also do not have the conductivity of true electric needles (silk threads are insulated); The placebo conductive patch used in the control group, although having the same appearance as the treatment group, is a specially insulated control substance. Therefore, even if the pulse generator is turned on and adjusted to medium intensity, the patient still receives zero current stimulation intensity. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The age range is 18-40 years old;
- Meets the diagnostic criteria for DOR as follows: ① AMH<1.1 ng/ml; ② 10 U/L < FSH < 25U/L or FSH/LH > 3.6; ③ The total number of follicles (AFC) in both basal sinuses is less than 7. If any two of the above criteria (①②③) are met, it can be diagnosed as DOR.
- At least one side of the patient's fallopian tube is unobstructed;
- The semen routine examination of the patient's spouse is normal;
- Voluntarily sign the informed consent form.
Key exclusion criteria (14 listed)
- Chromosomal or genetic abnormalities in either the female or male partner;
- Women with blocked fallopian tubes on both sides;
- Have a history of ovarian surgery, such as ovarian teratoma or ovarian chocolate cyst surgery;
- The female party suffers from uncorrected endocrine disorders such as simple hyperthyroidism or hypothyroidism, hyperprolactinemia, and pancreatic islet dysfunction;
- Hormone resistance, diabetes, adrenal diseases, etc;
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 |
|---|---|---|
| electro-thumbtack needleThe treatment acupoints include bilateral ovarian acupoints, Guan Yuan (CV4), bilateral Shen Shu (BL23), bilateral waist and eye acupoints (EX-B7), bilateral San Yin Jiao (SP6), and bilateral Zu San Li (ST36), totaling 11 acupoints. Among them, the bilateral ovarian acupoints and bilateral waist eye acupoints (EX-B7) were treated with electro-thumbtack needle. Other acupoints were treated with thumbtack needle.Choose a sparse and dense waveform, adjust the intensity to the maximum patient can tolerate, and stimulate for 30 minutes each time. After the stimulation is completed, remove the electrode patch and electroacupuncture device, and keep the electric needle at the acupoint for another 3 days.During the needle retention period, the electric needles at the bilateral ovarian acupoints and bilateral waist and eye acupoints were alternately stimulated once every other day using an electroacupuncture device for 30 minutes each time. | Other | electro-thumbtack needle group |
| placebo electro-thumbtack needleThe control group selected acupoints that were the same as the treatment group. Bilateral ovarian acupoints and bilateral waist and eye acupoints are treated with placebo electro-thumbtack needle, while other acupoints are treated with placebo electro-thumbtack needle. The treatment methods for placebo electro-thumbtack needle and placebo thumbtack needle are the same as those for the treatment group. | Other | Placebo group |
Primary outcome
live birth rate
Time frame: 3 months
The live birth rate is defined as the proportion of live births after 28 weeks of pregnancy, usually calculated by dividing the number of live birth cycles by the total number of patients and multiplying by 100%. This indicator is commonly used to evaluate the effectiveness of reproductive health centers or specific treatment methods, reflecting the ultimate outcome of successful pregnancy.
26 secondary outcomes
Biochemical pregnancy rate
Time frame: 3 months
clinical pregnancy rate
Time frame: 3 months
Threatened miscarriage rate
Time frame: 3 months
abortion rate
Time frame: 3 months
Anti Mullerian hormone (AMH)
Time frame: 3 months
Antral Follicle Count (AFC)
Time frame: 3 months
follicle stimulating hormone（FSH）
Time frame: 3 months
Luteinizing hormone (LH)
Time frame: 3 months
estradiol（E2）
Time frame: 3 months
Progesterone（P）
Time frame: 3 months
Prolactin（PRL）
Time frame: 3 months
Testosterone（T）
Time frame: 3 months
ZungSelf-RatingAnxietyScale（Zung-SAS）
Time frame: 3 months
Zung Self-rating depression scale(Zung-SDS)
Time frame: 3 months
Short form-36（SF-36）
Time frame: 3 months
Chinese Quality of Life Scale (CHQOL)
Time frame: 3 months
Self Rating Sleep Scale (SRSS)
Time frame: 3 months
The Sleep Disorders Rating Scale (SDRS)
Time frame: 3 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 months
corticotropin releasing hormone (CRH)
Time frame: 3 months
norepinephrine
Time frame: 3 month
epinephrine
Time frame: 3 months
5-hydroxytryptamine (5-HT)
Time frame: 3 months
gamma aminobutyric acid (GABA)
Time frame: 3 months
dopamine (DA)
Time frame: 3 months
beta endorphin (β - ET)
Time frame: 3 months
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 26 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing electro-thumbtack needle in people with Diminished Ovarian Reserve (DOR), run by Huazhong University of Science and Technology.
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 5 inclusion and 14 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: opening soon, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
live birth rate (time frame: 3 months). 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 26 Aug 2025.