Electroacupuncture for Diminished Ovarian Reserve

Guang'anmen Hospital of China Academy of Chinese Medical Sciences57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Irregular Menses

Interventions

EAOTHER

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.

HRT, DHEA and herbDRUG

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).

Eligibility

Sex: FEMALEMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

change of FSH from baseline

The follicle-stimulating hormone (FSH) will be tested at baseline and week 12

Time frame: baseline, week 12

Secondary Outcomes

change of FSH level from baseline

FSH will be tested at baseline and week 4, 8, 16, 20, and 24

Time frame: 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

Time frame: 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").

Time frame: 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

Time frame: baseline, weeks 8, 12 and 24

Data from ClinicalTrials.gov

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