Electroacupuncture for Diminished Ovarian Reserve

Phase 1

Completed

• Conditions: Irregular Menses
• Interventions: Other: EA; Drug: HRT, DHEA and herb

• Registration Number: NCT02229604
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-08-29
• Study First Posted: 2014-09-01
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EA group	EA	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).
EA group	HRT, DHEA and herb	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).
drug group	HRT, DHEA and herb	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.

Primary Outcome Measures

Name	Time	Method
change of FSH from baseline	baseline, week 12	The follicle-stimulating hormone (FSH) will be tested at baseline and week 12

Secondary Outcome Measures

Name	Time	Method
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