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Electroacupuncture for Diminished Ovarian Reserve

Primary Purpose

Irregular Menses

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

HRT, DHEA and herb

About this trial

This is an interventional treatment trial for Irregular Menses focused on measuring electroacupuncture, diminished ovarian reserve, cohort study

Eligibility Criteria

undefined - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EA group

drug group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

change of FSH from baseline

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

Secondary Outcome Measures

change of FSH level from baseline

FSH will be tested at baseline and 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

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").

proportion of patients regaining regular menses

The proportion of patients regaining regular menses at week8, 12 and 24 will be compared between groups

Full Information

NCT ID

NCT02229604

First Posted

August 25, 2014

Last Updated

October 6, 2016

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02229604

Brief Title

Electroacupuncture for Diminished Ovarian Reserve

Official Title

Electroacupuncture for Diminished Ovarian Reserve-a Cohort Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irregular Menses

Keywords

electroacupuncture, diminished ovarian reserve, cohort study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EA group

Arm Type

Experimental

Arm Description

Arm Title

drug group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Other Intervention Name(s)

acupuncture

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

HRT, DHEA and herb

Intervention Description

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 Measure Information:

Title

change of FSH from baseline

Description

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

Time Frame

baseline, week 12

Secondary Outcome Measure Information:

Title

change of FSH level from baseline

Description

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

Time Frame

baseline, week 4, 8, 16, 20, and 24

Title

changes in FSH/LH ratio, LH, and E2 from baseline

Description

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

Title

change of symptom scale

Description

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

Title

proportion of patients regaining regular menses

Description

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

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhishun Liu, Ph.D

Organizational Affiliation

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

27177929

Citation

Wang Y, Li Y, Chen R, Cui X, Yu J, Liu Z. Electroacupuncture for reproductive hormone levels in patients with diminished ovarian reserve: a prospective observational study. Acupunct Med. 2016 Oct;34(5):386-391. doi: 10.1136/acupmed-2015-011014. Epub 2016 May 13.

Results Reference

derived

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Electroacupuncture for Diminished Ovarian Reserve

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