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| Name | Class |
|---|---|
| Wuhan No.1 Hospital | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine | OTHER |
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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 function. In this trial, we hypothesize that electro-acupuncture is efficient for the ovarian function and the following outcome of IVF-ET in DOR patients.
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) will be taken.
Third, each patient will receive 24 sessions of acupuncture in 2-3 months, twice or three times a week.
Last, the above baseline measurements will be taken again as soon as the treatment is finished and outcome measures will be recorded after the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Active Comparator | Treatment group protocol：participants will receive electro-acupuncture twice or three times a week with a maximum of 24 times in 2-3 months. Each treatment session lasts for 30 minutes. |
|
| Control group | Sham Comparator | Control group protocol：participants will receive sham electro-acupuncture twice or three times a week with a maximum of 24 times in 2-3 months. Each treatment session lasts for 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment group protocol | Other | For treatment group, two groups of acupoints will be used alternatively. The first group consists of some acupoints. The patients will be asked to stay in supine position. Disposable sterilized needles (Size: 0.25*40/50 mm) will be inserted into a depth of 15~35 mm and stimulated manually to evoke needle sensation. And then some acupoints will be thereafter connected to electrical stimulators and stimulated with low-frequency and the maximum tolerated intensity of the patients. The other needles without electrical stimulators will be manually stimulated to evoke "Deqi" every 10 minutes. The second group consists of other acupoints. Patients will be asked to stay in prone position. The stimulation will be in the same way as the first group. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the change of ovarian reserve function | Assessing patients' ovarian reserve function before and after electro-acupuncture intervention, including: (1) The serum AMH, inhibin, and FSH and E2 levels on the third day of menstruation;(2) AFC. | 0 week and up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | the clinical pregnancy rate per cycle of IVF-ET after electro-acupuncture. | through study completion, an average of 1 year |
| Outcomes of IVF |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongmei Huang, doctor | Contact | 13971578190 | 02783663275 | hdmjcr@qq.com |
| Hanwang Zhang, doctor | Contact | 13386151967 | hwzhang605@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Dongmei Huang, doctor | Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 027 | China |
we use the Clinical Trial Management Public Platform to manage and share our date.
January, 2026, for 1 year
only for research
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| Edwatz Medical Research Institude | UNKNOWN |
| Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine | UNKNOWN |
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| Control group protocol | Other | For control group, four pseudo-acupoints are used, with two points on each shoulder and the two on each upper arm, which are not located on any meridians. The patients will be asked to stay in supine position and keep the whole body relaxed and comfortable. Disposable sterilized needles (Size: 0.18*25 mm) will be inserted superficially to a depth of < 5 mm without any manual stimulus and the needle sensation ("Deqi" in TCM) should not be evoked. Electrodes are connected to the needles, but the stimulators should be turned on at an intensity of zero. Each intervention lasts for 30 minutes. |
|
| through study completion, an average of 1 year |
| Blood biochemical index examination | Testing the levels of blood corticotrophin-releasing hormone (CRH), norepinephrine, adrenaline, 5-hydroxytryptamine, beta-aminobutyric acid (GABA), dopamine (DA) and neuro-endorphin of the patients before and after treatment. | 0 week and up to 12 weeks |
| Questionnaires | Evaluation of anxiety, depression, quality of life and sleep state is performed before and after treatment.
| 0 week and up to 4 weeks |
| Follow-up detection | Pregnancy patients will be followed up to the end of pregnancy. Adverse pregnancy outcomes and live birth rates will be recorded. Non-pregnant patients will be followed up for 1 year after treatment, testing the ovarian reserve function, follow-up treatment and pregnancy status of the patients within 1 year. | through study completion, an average of 1 year |