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Electroacupuncture for Diminished Ovarian Reserve

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ClinicalTrials.gov Identifier: NCT02229604
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Irregular Menses Other: EA Drug: HRT, DHEA and herb Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electroacupuncture for Diminished Ovarian Reserve—a Cohort Study
Study Start Date : January 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

Arm Intervention/treatment
Experimental: EA group
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
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.
Other Name: acupuncture

Drug: HRT, 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).

Active Comparator: drug group
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
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).




Primary Outcome Measures :
  1. change of FSH from baseline [ Time Frame: baseline, week 12 ]
    The follicle-stimulating hormone (FSH) will be tested at baseline and week 12


Secondary Outcome Measures :
  1. change of FSH level from baseline [ Time Frame: baseline, week 4, 8, 16, 20, and 24 ]
    FSH will be tested at baseline and week 4, 8, 16, 20, and 24

  2. changes in FSH/LH ratio, LH, and E2 from baseline [ Time Frame: 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

  3. change of symptom scale [ Time Frame: 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").

  4. proportion of patients regaining regular menses [ Time Frame: baseline, weeks 8, 12 and 24 ]
    The proportion of patients regaining regular menses at week8, 12 and 24 will be compared between groups



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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229604


Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
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Study Chair: Zhishun Liu, Ph.D Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liu Zhishun, Dean of Acupuncture Department of Guangan'men Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02229604     History of Changes
Other Study ID Numbers: ZZ0708081
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
electroacupuncture
diminished ovarian reserve
cohort study
Additional relevant MeSH terms:
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Menstruation Disturbances
Pathologic Processes