Electroacupuncture for Diminished Ovarian Reserve

NCT02229604 | Completed Phase 1

• 1 other identifier: ZZ0708081
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irregular Menses

Keywords

electroacupuncture; diminished ovarian reserve; cohort study

Outcome Measures

Primary Outcomes (1)

• change of FSH from baseline

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

  baseline, week 12

Secondary Outcomes (4)

• change of FSH level from baseline

  baseline, 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

• change of symptom scale

  baseline, week 12, week 24

• proportion of patients regaining regular menses

  baseline, weeks 8, 12 and 24

Study Arms (2)

EA group

EXPERIMENTAL

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; Drug: HRT, DHEA and herb

drug group

ACTIVE COMPARATOR

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

Interventions

EA OTHER

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.

Also known as: acupuncture

EA group

HRT, DHEA and herb DRUG

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).

EA group; drug group

Eligibility Criteria

• Age: Up to 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age younger than 40 yr
• IU/L ≤ FSH ≤ 40IU/L
• Volunteer to join the research and give the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Related Publications (1)

• 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.

  PMID: 27177929 DERIVED

MeSH Terms

Conditions

Menstruation Disturbances

Interventions

Acupuncture Therapy; Hormone Replacement Therapy; Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Drug Therapy; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Zhishun Liu, Ph.D

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Acupuncture Department of Guangan'men Hospital

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: September 1, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 10, 2016

Record last verified: 2016-10