Electroacupuncture for Diminished Ovarian Reserve

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 1

Conditions: Irregular Menses

Treatments: Other: EA; Drug: HRT, DHEA and herb

Study type: Interventional

Funder types: Other

Identifiers

NCT02229604

ZZ0708081

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: Female

Ages: Under 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

57 participants in 2 patient groups

EA group

Experimental group

Description:

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).

Treatment:

Drug: HRT, DHEA and herb

Other: EA

drug group

Active Comparator group

Description:

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.

Treatment:

Drug: HRT, DHEA and herb