Diminished Ovarian ReserveNCT06395623
Study of Acupoints in Diminished Ovarian Reserve Based on Biological Characteristics
An observational study of Diminished Ovarian Reserve, run by Xiaomei Shao at 1 site in China.
Trial summary
Diminished Ovarian Reserve (DOR) is characterized by decreased female fertility, menstrual disorders and perimenopausal symptoms due to sex hormone deficiency or fluctuations. For now, there are no uniform diagnostic criteria or an ideal single detection index for DOR because of its insidious etiology and… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diminished Ovarian Reserve
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2024to 30 Dec 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: This study targets at patients with DOR and healthy participants. The diagnostic criteria of DOR were based on<Consensus on Cinical Diagnosis and Management of Diminished Ovarian Reserve(2022)> and <Obstetrics and Gynecology(9th edition)>
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.
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- healthy participants who can provide medical examination reports within the past 1 year and have routine physical examination conducted by researchers to confirm that there are no serious underlying diseases of the reproductive system, urinary system, blood, endocrine, nervous system, etc.;
- without symptoms of oligomenorrhea or amenorrhea at present;
- between the ages of 18 to 40, female;
- without any mind disease, volunteering to participate in the study and sign the informed consent.
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.
- Patient with mental illness, severe depression, alcohol dependence or a history of drug abuse;
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- In pregnant or breastfeeding;
- abnormal body temperature at present;
- Participants who are currently participating in other clinical trials or who do not 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, +8618957130287, shaoxiaomei@zcmu.edu.cn
Hanyu Liu, +8617857314691, 912782196@qq.com
About this study
Official title: Study of Acupoints in Diminished Ovarian Reserve Based on Biological Characteristics：A Case-control Study
Diminished Ovarian Reserve (DOR) is characterized by decreased female fertility, menstrual disorders and perimenopausal symptoms due to sex hormone deficiency or fluctuations. For now, there are no uniform diagnostic criteria or an ideal single detection index for DOR because of its insidious etiology and pathogenesis,theories suggest that there are specific changes in the body surface or acupuncture points in a pathological state. By detecting the biological characteristics of relevant meridian points and exploring the specificity and regularity of it.
Read the detailed description
There will be a multi-center, case-control, observational experiment. 50 patients with DOR and 50 healthy participants will be involved from Third Affiliated Hospital of Zhejiang Chinese Medicine University, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medicine University and social recruitment. Modern instruments are used to regularly test the pain threshold, infrared thermal image, resistance, micro-circulation, and biological ultra-weak luminescence. There will be no randomized methods and blindness for subjects, while assessors and statisticians are masked from patients or healthy people. The study is aim to explore the the relevance between meridian acupoints and DOR.
- Conditions
- Diminished Ovarian Reserve
- Keywords
- Biological Characteristics, Acupoint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with DOR | 50 patients diagnosed with DOR will be recruited in this group to get detectionsof pain threshold, infrared thermal image, resistance, micro-circulation, and biological ultra-weak luminescence at the relevant body surface areas and meridian acupoints and the blood test of serum FSH(follicle-stimulating hormone) and AMH(Anti-Müllerian Hormone). | |
| Healthy participants | 50 healthy participants in this group will achieve the same detections of biological characteristics and blood test as well. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature of acupoint by infrared thermal image
Infrared thermography (The NEC R550 infrared thermal imager and the InfRec Analyzer NS9500 computer software) will be used to measured the temperature of the meridian acupoints. The measurements are taken at participants' follicular phase.
Measured: baseline
Pain threshold
Pain threshold of related acupoints will be tested by pressure pain threshold gauge (PTG). Assessors will put continuous pressure on the surface of acupoints vertically until participants feel pain to measure the threshold.
Measured: baseline
Secondary outcomes (3)
Serum follicle-stimulating hormone (FSH)
The increasing of FSH is widely clinical accepted for measuring ovarian function, which is one of the main symptoms of Diminished Ovarian Reserve. Participants in this study will be asked to take the serum FSH text between day2 to day4 of menstrual period in whole observation.
Measured: baseline
Serum Anti-Müllerian Hormone (AMH)
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. The serum AMH will be measured on day 2-4 of the menstrual cycle at the basement and the end of the treatment.
Measured: baseline
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start24 Mar 2024
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 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, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395623
- Sponsor's protocol ID
- 2022YFC3500401
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 6 May 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 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Acupoints in Diminished Ovarian Reserve Based on Biological Characteristics：A Case-control Study
- ClinicalTrials.gov ID
- NCT06395623
- Acronym / sponsor ID
- 2022YFC3500401
- Conditions
- Diminished Ovarian Reserve
- Keywords
- Biological Characteristics, Acupoint
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xiaomei ShaoUniversity, hospital or other
- Collaborators
- Hangzhou Hospital of Traditional Chinese Medicine
- Study start
- 24 Mar 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 2 May 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 by decreased female fertility, menstrual disorders and perimenopausal symptoms due to sex hormone deficiency or fluctuations. For now, there are no uniform diagnostic criteria or an ideal single detection index for DOR because of its insidious etiology and pathogenesis,theories suggest that there are specific changes in the body surface or acupuncture points in a pathological state. By detecting the biological characteristics of relevant meridian points and exploring the specificity and regularity of it.
Detailed description
There will be a multi-center, case-control, observational experiment. 50 patients with DOR and 50 healthy participants will be involved from Third Affiliated Hospital of Zhejiang Chinese Medicine University, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medicine University and social recruitment. Modern instruments are used to regularly test the pain threshold, infrared thermal image, resistance, micro-circulation, and biological ultra-weak luminescence. There will be no randomized methods and blindness for subjects, while assessors and statisticians are masked from patients or healthy people. The study is aim to explore the the relevance between meridian acupoints and DOR.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with DOR | – | –50 patients diagnosed with DOR will be recruited in this group to get detectionsof pain threshold, infrared thermal image, resistance, micro-circulation, and biological ultra-weak luminescence at the relevant body surface areas and meridian acupoints and the blood test of serum FSH(follicle-stimulating hormone) and AMH(Anti-Müllerian Hormone). |
| Healthy participants | – | –50 healthy participants in this group will achieve the same detections of biological characteristics and blood test as well. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study targets at patients with DOR and healthy participants. The diagnostic criteria of DOR were based on<Consensus on Cinical Diagnosis and Management of Diminished Ovarian Reserve(2022)> and <Obstetrics and Gynecology(9th edition)>
Key inclusion criteria (10 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.
- healthy participants who can provide medical examination reports within the past 1 year and have routine physical examination conducted by researchers to confirm that there are no serious underlying diseases of the reproductive system, urinary system, blood, endocrine, nervous system, etc.;
Key exclusion criteria (9 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.
Primary outcome
Temperature of acupoint by infrared thermal image
Time frame: baseline
Infrared thermography (The NEC R550 infrared thermal imager and the InfRec Analyzer NS9500 computer software) will be used to measured the temperature of the meridian acupoints. The measurements are taken at participants' follicular phase.
Pain threshold
Time frame: baseline
Pain threshold of related acupoints will be tested by pressure pain threshold gauge (PTG). Assessors will put continuous pressure on the surface of acupoints vertically until participants feel pain to measure the threshold.
3 secondary outcomes
Serum follicle-stimulating hormone (FSH)
Time frame: baseline
Serum Anti-Müllerian Hormone (AMH)
Time frame: baseline
The modified Kupperman Index(KI)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
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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 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?
An observational study of 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 10 inclusion and 9 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 6 May 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. 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 (+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?
Temperature of acupoint by infrared thermal image (time frame: baseline). 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 6 May 2024.