Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve
NCT ID: NCT06223178
Last Updated: 2024-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
106 participants
INTERVENTIONAL
2023-11-03
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Thumb-tack needle acupuncture
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.
thumb-tack needle
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.
Basic gynecological treatment
Gynecological health care guidance will be provided as patients needed.
Sham acupuncture group
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.
sham thumb-tack needle
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 treatment
Gynecological health care guidance will be provided as patients needed.
Interventions
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thumb-tack needle
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 needle
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 treatment
Gynecological health care guidance will be provided as patients needed.
Eligibility Criteria
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Inclusion Criteria
* 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):
1. 10 IU/L \< FSH \< 20 IU/L,
2. 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.
Exclusion Criteria
* 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.
18 Years
39 Years
FEMALE
No
Sponsors
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Hangzhou Hospital of Traditional Chinese Medicine
OTHER
Xiaomei Shao
OTHER
Responsible Party
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Xiaomei Shao
Professor
Principal Investigators
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Xiaomei Shao, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The Third Affiliated hospital of Zhejiang Chinese Medical University
Locations
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the Third affiliated hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023ZX010-DOR
Identifier Type: -
Identifier Source: org_study_id
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