Irregular Menses
Conditions
Keywords
electroacupuncture, diminished ovarian reserve, cohort study
Brief summary
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.
Interventions
OTHEREA
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.
DRUGHRT, DHEA and herb
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).
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of FSH from baseline | baseline, week 12 | The follicle-stimulating hormone (FSH) will be tested at baseline and week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of FSH level from baseline | baseline, week 4, 8, 16, 20, and 24 | FSH will be tested at baseline and week 4, 8, 16, 20, and 24 |
| changes in FSH/LH ratio, LH, and E2 from baseline | baseline, week 4, 8, 12, 16, 20, and 24 | FSH/LH ratio, LH, and E2 will be tested at baseline and week 4, 8, 12, 16, 20, and 24 |
| change of symptom scale | baseline, week 12, week 24 | 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). |
| proportion of patients regaining regular menses | baseline, weeks 8, 12 and 24 | The proportion of patients regaining regular menses at week8, 12 and 24 will be compared between groups |
Outcome results
None listed