NCT04972877

Effect of Electro-acupuncture on Women With Diminished Ovarian Reserve

Effect of Electro-acupuncture on Ovarian Function and Outcome of IVF-ET of Women With Diminished Ovarian Reserve：a Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 338 (estimated)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

First, patients will be recruited according to the inclusion criteria and exclusion criteria. Second, baseline measurements (including ovarian reserve function, blood biochemical index, scores from the self-rating anxiety and depression scale, quality of life) will be taken. Third, each patient will receive 24 sessions of acupuncture in 2-3 months, twice or three times a week. Last, the above baseline measurements will be taken again as soon as the treatment is finished and outcome measures will be recorded after the treatment.

Conditions

• Diminished Ovarian Reserve

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-09
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2021-07-22
• Last updated: 2021-07-22

Locations

1 site across 1 country: China