Diminished Ovarian ReserveNCT06223178
Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve
A study testing thumb-tack needle and Basic gynecological treatment in people with Diminished Ovarian Reserve, run by Xiaomei Shao at 1 site in China.
Trial summary
Diminished Ovarian Reserve (DOR) is characterized as an important cause of infertility. Acupuncture has been extensively used to treat female infertility. This study was conducted to investigate the efficacy of thumb-tack needle，as a new special type of acupuncture and long-lasting treatment modality,in the treatment… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve
- What is being tested?
- thumb-tack needle and Basic gynecological treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2023to 30 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years old ≤ age < 40 years old, female;
- Clinical diagnosis of Diminished Ovarian Reserve: meet both items in twice tests with an interval of at least 4 weeks(tested between 2rd to 4th day of menstrual cycle):
- 10 IU/L < FSH < 20 IU/L,
- Anti-Müllerian hormone(AMH) < 1.1ng/mL.
- without any mind disease, willing to participate in the study and sign the informed consent.
- without any other treatment.
Who cannot join
- Low or no response to exogenous gonadotropins, or with congenital anomalies in the development of the reproductive tract；
- Pregnant or breastfeeding;
- Abnormal body temperatures at the moment;
- Psychopath, alcoholic, Patient with severe depression, history of substance abuse and severe primary diseases of cardiovascular, liver, kidney and hematopoietic system;
- Currently enrolled in other clinical trials or refuse to cooperate with the study protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Third affiliated hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang
Xiaomei Shao, Ph.D, +8618957130287, shaoxiaomei@zcmu.edu.cn
Hanyu Liu, +8617857314691, 912782196@qq.com
About this study
Official title: Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve: Study Protocol for a Randomized Controlled Trial
Diminished Ovarian Reserve (DOR) is characterized as an important cause of infertility. Acupuncture has been extensively used to treat female infertility. This study was conducted to investigate the efficacy of thumb-tack needle，as a new special type of acupuncture and long-lasting treatment modality,in the treatment of DOR.
Read the detailed description
There will be a multi-center, randomized, sham-controlled trial. 106 patients will be randomly assigned into thumb-tack needle acupuncture or sham-acupuncture in 1:1 ratio. All the patents will achieve 12 sessions of verum or sham treatments in 20 weeks(12 weeks for treatment and 8 weeks for follow-up). Patients, outcome assessors and statisticians are masked from group assignment. The study is aim to evaluate the efficacy of thumb-tack needle for DOR.
- Conditions
- Diminished Ovarian Reserve
- Being tested
- thumb-tack needle, sham thumb-tack needle, Basic gynecological treatment
- Keywords
- Diminished Ovarian Reserve, Acupoint, Thumb-tack Needle, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thumb-tack needleDevice
Sterilizing skin and avoiding vessels, the thumb-tack needle are directly stock to the surface of acupoints by a band-aid, kneading and pressing for 5 minutes. The thumb-tack needle will be embedded in the skin and keep staying for 72 hours. Patients will be taught to press them 3 to 4 times per day. As tolerated by them, each pressing will lasts 1 minutes with an interval of about 4 hours.
sham thumb-tack needleDevice
Sterilizing skin and avoiding vessels, the sham thumb-tack needle are directly stock to the surface of acupoints by a band-aid, kneading and pressing for 5 minutes. The sham device will be embedded in the skin and keep staying for 72 hours. Patients will be taught to press them 3 to 4 times per day. As tolerated by them, each pressing will lasts 1 minutes with an interval of about 4 hours.
Basic gynecological treatmentOther
Gynecological health care guidance will be provided as patients needed.
| Study group | Role | What they receive |
|---|---|---|
| Thumb-tack needle acupuncture | Experimental | 53 Patients in this group will achieve 24 sessions treatment of thumb-tack needle in 12 consecutive weeks. Treatment will be operated by trained acupuncturists. Receives: Device: thumb-tack needle; Other: Basic gynecological treatment |
| Sham acupuncture group | Sham comparator | A sham thumb-tack needle, which has no difference in appearance with the verum thumb-tack needle but is lack of needle, are used for 53 patient in this group. 24 sessions of treatment will be performed in 12 consecutive weeks. Treatment will be operated by trained acupuncturists. Receives: Device: sham thumb-tack needle; Other: Basic gynecological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of serum follicle-stimulating hormone (FSH) level
The increasing of serum follicle-stimulating hormone（FSH） is one of the main symptoms of Diminished Ovarian Reserve. The normal value of FSH is 1.37-9.9 U/L in follicular phase, and higher the FSH value, the worse ovarian function. Patients in this study will be asked to take the serum FSH text between day2 to day4 of menstrual period in whole observation. Patients with amenorrhea take every 28 days as a supposed menstrual cycle instead.
Measured: baseline，week 4, week 12，week 20(week 8 in follow-up)
Secondary outcomes (7)
changes of 1.Serum Anti-Müllerian Hormone (AMH) level
AMH is another recommend index to measure ovarian function. Compared to FSH, Anti-Müllerian Hormone has less fluctuation and more accuracy. The normal value of serum AMH is 2-6.8ng/ml in follicular phase, and lower the value, the worse condition.
Measured: baseline，week 12, week 20(week 8 in follow-up)
temperature of sensitized acupoint
"Acupoint sensitization" suggests that there are specific changes of biological characteristics on the body surface or acupuncture points in a pathological state. Acupoints associated with the disease may manifest as sensitivity to pain and heat. Infrared thermography (IRT) will be used to measured the temperature of the DOR-related acupoints.
Measured: baseline，week 4, week 12，week 20(week 8 in follow-up)
pain threshold of sensitized acupoint
Pain threshold of DOR-related acupoints will be tested by pressure pain threshold gauge (PTG).
Measured: baseline，week 4, week 12，week 20(week 8 in follow-up)
the modified Kupperman Index(KI)
The modified Kupperman Index (KI) is widely used for female self-evaluation of the severity of menopausal symptoms in clinical practice. It values 13 items of menopausal symptoms on a scale of 0 to 3. The final score of KI is the sum of each score multiplied with the base score respectively, ranging from 0-63. The final KI score is less than 6 means normal, between 6 to 15 are classified as mild, 16 to 30 as moderate, and greater than 30 as severe.
Measured: baseline，week 4, week 12，week 20(week 8 in follow-up)
Self-Rating Anxiety Scale (SAS)
According to the frequency of symptom occurrence, the SAS contains 20 items reflecting subjective feelings of anxiety, and each item is rated on a four-point scale of 1 to 4, including 15 positive and 5 negative items. 1 means never, 2 is for sometimes, 3 is for frequently, 4 is always. Positive items are rating from 1-4, while negative items is from 4 to 1. Once the evaluation is complete, the scores for each of the 20 items are added together as score X. Score X will multiply by 1.25 and then round to the nearest whole number to obtain a standardized score Y, which is the final result of SAS. According to the Chinese normative results, the cut-off value of the SAS standardized score is 50, where 50-59 is mild anxiety, 60-69 is moderate anxiety, and 69 or more is severe anxiety.
Measured: baseline，week 4, week 12，week 20(week 8 in follow-up)
Self-rating Depression Scale (SDS)
The SDS also contains 20 items reflecting subjective feelings of depression, with 10 positive and 10 negative ratings. 1 means never, 2 is for sometimes, 3 is for frequently, 4 is always. Positive items are rating from 1-4, while negative items is from 4 to 1. Once the evaluation is complete, the scores for each of the 20 items are added together as score X. Score X will multiply by 1.25 and then round to the nearest whole number to obtain a standardized score Y, which is the final result of SDS.The cut-off value of SDS standardized score is 53, where 53 to 62 is considered as mild depression, 63 to 72 is moderate depression, and 72 or more is severe depression.
Measured: baseline，week 4, week 12，week 20(week 8 in follow-up)
Psychological constitution of traditional Chinese medicine(TCM）
The TCM psychological constitution scale is compiled by Professor Wang Qi of Beijing University of Chinese Medicine, which is widely used in clinical practice. There are 9 items and 66 small items in the TCM constitution scale, and it requires patients fill the scale truthfully by themselves according to their real situation in the last year. Nine psychological constitutions will be determined by conversion score: mild constitution, qi deficiency constitution, qi depression constitution, yin deficiency constitution, yang deficiency constitution, blood stasis constitution, special constitution, phlegm-dampness constitution and damp-heat constitution.
Measured: baseline，week 4, week 12，week 20(week 8 in follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start3 Nov 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaomei Shao
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Xiaomei Shao, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Xiaomei Shao, Ph.D, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223178
- Sponsor's protocol ID
- 2023ZX010-DOR
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06223178
- Acronym / sponsor ID
- 2023ZX010-DOR
- Conditions
- Diminished Ovarian Reserve
- Keywords
- Diminished Ovarian Reserve, Acupoint, Thumb-tack Needle, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Xiaomei ShaoUniversity, hospital or other
- Collaborators
- Hangzhou Hospital of Traditional Chinese Medicine
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 Jan 2024 (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.
Diminished Ovarian Reserve (DOR) is characterized as an important cause of infertility. Acupuncture has been extensively used to treat female infertility. This study was conducted to investigate the efficacy of thumb-tack needle，as a new special type of acupuncture and long-lasting treatment modality,in the treatment of DOR.
Detailed description
There will be a multi-center, randomized, sham-controlled trial. 106 patients will be randomly assigned into thumb-tack needle acupuncture or sham-acupuncture in 1:1 ratio. All the patents will achieve 12 sessions of verum or sham treatments in 20 weeks(12 weeks for treatment and 8 weeks for follow-up). Patients, outcome assessors and statisticians are masked from group assignment. The study is aim to evaluate the efficacy of thumb-tack needle for DOR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thumb-tack needle acupuncture | Experimental | Device: thumb-tack needle, Other: Basic gynecological treatment53 Patients in this group will achieve 24 sessions treatment of thumb-tack needle in 12 consecutive weeks. Treatment will be operated by trained acupuncturists. |
| Sham acupuncture group | Sham comparator | Device: sham thumb-tack needle, Other: Basic gynecological treatmentA sham thumb-tack needle, which has no difference in appearance with the verum thumb-tack needle but is lack of needle, are used for 53 patient in this group. 24 sessions of treatment will be performed in 12 consecutive weeks. Treatment will be operated by trained acupuncturists. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 years old ≤ age < 40 years old, female;
- Clinical diagnosis of Diminished Ovarian Reserve: meet both items in twice tests with an interval of at least 4 weeks(tested between 2rd to 4th day of menstrual cycle):
- without any mind disease, willing to participate in the study and sign the informed consent.
- without any other treatment.
Key exclusion criteria (5 listed)
- Low or no response to exogenous gonadotropins, or with congenital anomalies in the development of the reproductive tract；
- Pregnant or breastfeeding;
- Abnormal body temperatures at the moment;
- Psychopath, alcoholic, Patient with severe depression, history of substance abuse and severe primary diseases of cardiovascular, liver, kidney and hematopoietic system;
- Currently enrolled in other clinical trials or refuse to cooperate with the study protocol.
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 |
|---|---|---|
| thumb-tack needleSterilizing skin and avoiding vessels, the thumb-tack needle are directly stock to the surface of acupoints by a band-aid, kneading and pressing for 5 minutes. The thumb-tack needle will be embedded in the skin and keep staying for 72 hours. Patients will be taught to press them 3 to 4 times per day. As tolerated by them, each pressing will lasts 1 minutes with an interval of about 4 hours. | Device | Thumb-tack needle acupuncture |
| sham thumb-tack needleSterilizing skin and avoiding vessels, the sham thumb-tack needle are directly stock to the surface of acupoints by a band-aid, kneading and pressing for 5 minutes. The sham device will be embedded in the skin and keep staying for 72 hours. Patients will be taught to press them 3 to 4 times per day. As tolerated by them, each pressing will lasts 1 minutes with an interval of about 4 hours. | Device | Sham acupuncture group |
| Basic gynecological treatmentGynecological health care guidance will be provided as patients needed. | Other | Sham acupuncture group, Thumb-tack needle acupuncture |
Primary outcome
changes of serum follicle-stimulating hormone (FSH) level
Time frame: baseline，week 4, week 12，week 20(week 8 in follow-up)
The increasing of serum follicle-stimulating hormone（FSH） is one of the main symptoms of Diminished Ovarian Reserve. The normal value of FSH is 1.37-9.9 U/L in follicular phase, and higher the FSH value, the worse ovarian function. Patients in this study will be asked to take the serum FSH text between day2 to day4 of menstrual period in whole observation. Patients with amenorrhea take every 28 days as a supposed menstrual cycle instead.
7 secondary outcomes
changes of 1.Serum Anti-Müllerian Hormone (AMH) level
Time frame: baseline，week 12, week 20(week 8 in follow-up)
temperature of sensitized acupoint
Time frame: baseline，week 4, week 12，week 20(week 8 in follow-up)
pain threshold of sensitized acupoint
Time frame: baseline，week 4, week 12，week 20(week 8 in follow-up)
the modified Kupperman Index(KI)
Time frame: baseline，week 4, week 12，week 20(week 8 in follow-up)
Self-Rating Anxiety Scale (SAS)
Time frame: baseline，week 4, week 12，week 20(week 8 in follow-up)
Self-rating Depression Scale (SDS)
Time frame: baseline，week 4, week 12，week 20(week 8 in follow-up)
Psychological constitution of traditional Chinese medicine(TCM）
Time frame: baseline，week 4, week 12，week 20(week 8 in follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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Guishen Yijing Granules for Diminished Ovarian Reserve With Kidney Deficiency Syndrome: A Randomized Controlled Trial
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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.
Xiaomei Shao, Ph.D principal investigator
The Third Affiliated hospital of 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 thumb-tack needle and Basic gynecological treatment in people with Diminished Ovarian Reserve, run by Xiaomei Shao 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaomei Shao, Ph.D (+8618957130287, shaoxiaomei@zcmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of serum follicle-stimulating hormone (FSH) level (time frame: baseline，week 4, week 12，week 20(week 8 in follow-up)). 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 30 Jan 2024.