Electroacupuncture for Diminished Ovarian Reserve

Study Overview
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Brief Summary
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Diminished ovarian reserve (DOR)is a disease can not be cured. Medicine for DOR includes dehydroepiandrosterone (DHEA), hormone replacement therapy (HRT), immunosuppressive agents and alternative therapy, etc. Electroacupuncture (EA) can help patients regain regular menses, increase the estradiol (E2) level and decrease the follicle-stimulating hormone (FSH) and decrease FSH/luteotropic (LH) ratio. In this cohort study, we aim to observe the effect of EA versus other therapies for DOR.

Official Title
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Electroacupuncture for Diminished Ovarian Reserve-a Cohort Study

Conditions
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Irregular Menses

Intervention / Treatment
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* Other: EA
* Drug: HRT, DHEA and herb


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age younger than 40 yr 10IU/L ≤ FSH ≤ 40IU/L Volunteer to join the research and give the informed consent Exclusion Criteria: A history of ovariectomy, receiving cytotoxic chemotherapy or irradiation Reproductive system infection or tumor Autoimmune disease Amenorrhea due to reproduction abnormality or pregnancy Patients can not adhere to treatment due to personal situation Patients have taken immunosuppressive agents in past 6 months receive treatment for less than 1 week before withdrawal

Ages Eligible for Study
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Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EA group<br>Patients choose this group will receive EA as a combination. Beside of EA, participants could receive oral medicine as the same as that of the drug group. The EA regimen has two point formulae, i.e. A (BL33) and B (ST25, EX-CA1 and RN4). The two formulae will be used alternatively. One session will last for 20 minutes, 5 sessions per week for the first 4 weeks and 3 sessions per week later (44 sessions in all). | Other: EA<br>* For BL33, insert the needle to the third posterior sacral foramina to a depth of 80-100mm. For ST25, EX-CA1 and RN4, the needle will be inserted vertically and quickly through the skin, and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall (until the moment of resistance is sensed on the tip of the needle and the participant feels a sting). The electric stimulator will be put on the BL33 and EX-CA1 with a continuous wave, 20 Hz, 1.0-4.0 mA.<br>* Other names: acupuncture;Drug: HRT, DHEA and herb<br>* HRT, dehydroepiandrosterone (DHEA) and herb decoction could be used for this group. Time frame of treatment is not fixed. Herb decoction will be given to participants based on the principle of syndrome differentiation (a diagnosing method in Traditional Chinese Medicine).<br>|
| Active Comparator: drug group<br>Hormone replacement therapy (HRT), DHEA and herb decoction are allowed to be used for this group. Treatment course is not fixed. Immunosuppressive agents are not allowed. | Drug: HRT, DHEA and herb<br>* HRT, dehydroepiandrosterone (DHEA) and herb decoction could be used for this group. Time frame of treatment is not fixed. Herb decoction will be given to participants based on the principle of syndrome differentiation (a diagnosing method in Traditional Chinese Medicine).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of FSH from baseline | The follicle-stimulating hormone (FSH) will be tested at baseline and week 12 | baseline, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of FSH level from baseline | FSH will be tested at baseline and week 4, 8, 16, 20, and 24 | baseline, week 4, 8, 16, 20, and 24 | 
| changes in FSH/LH ratio, LH, and E2 from baseline | FSH/LH ratio, LH, and E2 will be tested at baseline and week 4, 8, 12, 16, 20, and 24 | baseline, week 4, 8, 12, 16, 20, and 24 | 
| change of symptom scale | Symptoms need to be assessed include irritability and depression. A 4-point scale is used to evaluate the degree of symptoms (0 means not at all and 3 means severe). | baseline, week 12, week 24 | 
| proportion of patients regaining regular menses | The proportion of patients regaining regular menses at week8, 12 and 24 will be compared between groups | baseline, weeks 8, 12 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electroacupuncture, diminished ovarian reserve, cohort study