Electroacupuncture for Diminished Ovarian Reserve

Irregular Menses Clinical Trial

Official title:

Electroacupuncture for Diminished Ovarian Reserve—a Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229604
• Other study ID #: ZZ0708081
• Status: Completed
• Phase: Phase 1
• First received: August 25, 2014
• Last updated: October 6, 2016
• Start date: January 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irregular Menses

Intervention

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.

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of FSH from baseline	The follicle-stimulating hormone (FSH) will be tested at baseline and week 12	baseline, week 12	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No