Using thumbtack needles to improve ovarian function in women with diminished ovarian reserve
Effect of Thumbtack Needle on Ovarian Function of Women With Diminished Ovarian Reserve (DOR): A Randomized Controlled Clinical Trial
This study is testing whether acupuncture with thumbtack needles can help improve ovarian function in women who have diminished ovarian reserve.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Huazhong University of Science and Technology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05277948 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of thumbtack needle acupuncture on ovarian function in women diagnosed with diminished ovarian reserve (DOR). It employs a multi-center, randomized, controlled, and blind design to ensure robust results. Participants will undergo baseline assessments followed by treatment with either active or sham thumbtack needles over two menstrual cycles, with subsequent evaluations to measure changes in ovarian function and overall well-being. The study aims to provide insights into alternative treatment options for women facing reproductive challenges due to DOR.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 40 with low ovarian reserve indicators.
Not a fit: Patients with chromosomal abnormalities, previous ovarian surgeries, or uncorrected endocrine diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance ovarian function and improve reproductive outcomes for women with diminished ovarian reserve.
How similar studies have performed: Previous studies have shown acupuncture to be beneficial for ovarian function, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with age between 18 and 40 years; * Low ovarian reserve: AMH\<1.1ng/ml; or AFC\<7; or 10 U/L\<FSH\<25U/L or FSH/LH\>3.6; or has a history of poor ovarian response, that is, in the last controlled hyperstimulation cycle, the number of retrieved oocytes\<3. Any 2 of the above 4 conditions are met. * Sign informed consent voluntarily. Exclusion Criteria: * Patient's chromosome is abnormal. * Patients with previous ovarian surgery because of such as ovarian teratoma or chocolate cyst and so on. * Patients with uncorrected endocrine disease, such as: Simple hyperthyroidism or hypothyroidism, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, etc. * Patients with definitively diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, Sjogren's syndrome, Hashimoto's thyroiditis. * Patients with a history of cancer and has received radiotherapy or chemotherapy. * Patients had the treatment of acupuncture or thumbtack needle in recent 3 months. * Patients who take Chinese medicine decoction or granule during the treatment; * Patients unwilling to sign the informed consent of this study.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Hanwang Zhang — Huazhong University of Science Tech
- Study coordinator: Dongmei Huang
- Email: hdmjcr@qq.com
- Phone: 86-27-83663275
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.