Electroacupuncture for Diminished Ovarian Reserve

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02229604
• Collaborator: (none)
• Enrollment: 57
• Arms: 2
• Duration (Months): 32

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Irregular Menses	Other: EA; Drug: HRT, DHEA and herb	Phase 1

Study Design

• Study Type: Interventional
• 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: Jan 1, 2014
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. change of FSH from baseline [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 [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 [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 [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 [baseline, weeks 8, 12 and 24]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: ZZ0708081
• First Posted: Sep 1, 2014
• Last Update Posted: Oct 10, 2016
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Liu Zhishun, Dean of Acupuncture Department of Guangan'men Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences: electroacupuncture; diminished ovarian reserve; cohort study
• Additional relevant MeSH terms: Menstruation Disturbances

Study Results

No Results Posted as of Oct 10, 2016