Electroacupuncture for Diminished Ovarian Reserve

Electroacupuncture for Diminished Ovarian Reserve-a Cohort Study

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 Overview

• Status: Completed
• Conditions: Irregular Menses
• Intervention / Treatment: Other: EA; Drug: HRT, DHEA and herb

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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).

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: August 25, 2014
• First Submitted That Met QC Criteria: August 29, 2014
• First Posted (Estimate): September 1, 2014

Study Record Updates

• Last Update Posted (Estimate): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: cohort study; electroacupuncture; diminished ovarian reserve
• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances
• Other Study ID Numbers: ZZ0708081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided