Effect of Electro-acupuncture on Women With Diminished Ovarian Reserve

NCT04972877 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2021-07-22

No results posted yet for this study

Summary

Diminished ovarian reserve (DOR) is the precursor state of ovarian failure, and can cause the decline of women's reproductive function. Some studies have demonstrated that acupuncture can improve ovarian function. In this trial, we hypothesize that electro-acupuncture is efficient for the ovarian function and the following outcome of IVF-ET in DOR patients.

Conditions

  • Diminished Ovarian Reserve

Interventions

OTHER

Treatment group protocol

For treatment group, two groups of acupoints will be used alternatively. The first group consists of some acupoints. The patients will be asked to stay in supine position. Disposable sterilized needles (Size: 0.25\*40/50 mm) will be inserted into a depth of 15\~35 mm and stimulated manually to evoke needle sensation. And then some acupoints will be thereafter connected to electrical stimulators and stimulated with low-frequency and the maximum tolerated intensity of the patients. The other needles without electrical stimulators will be manually stimulated to evoke "Deqi" every 10 minutes. The second group consists of other acupoints. Patients will be asked to stay in prone position. The stimulation will be in the same way as the first group.

OTHER

Control group protocol

For control group, four pseudo-acupoints are used, with two points on each shoulder and the two on each upper arm, which are not located on any meridians. The patients will be asked to stay in supine position and keep the whole body relaxed and comfortable. Disposable sterilized needles (Size: 0.18\*25 mm) will be inserted superficially to a depth of \< 5 mm without any manual stimulus and the needle sensation ("Deqi" in TCM) should not be evoked. Electrodes are connected to the needles, but the stimulators should be turned on at an intensity of zero. Each intervention lasts for 30 minutes.

Sponsors & Collaborators

  • Wuhan No.1 Hospital

    collaborator OTHER
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER
  • The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

    collaborator OTHER
  • Edwatz Medical Research Institude

    collaborator UNKNOWN
  • Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine

    collaborator UNKNOWN
  • Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Dongmei Huang, doctor · Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-09
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04972877 on ClinicalTrials.gov