Treatment for Diminished Ovarian Reserve using Thumb-tack Needles
Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve: Study Protocol for a Randomized Controlled Trial
NA · The Third Affiliated hospital of Zhejiang Chinese Medical University · NCT06223178
This study is testing if acupuncture with thumb-tack needles can help women with Diminished Ovarian Reserve improve their chances of getting pregnant.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | Female |
| Sponsor | The Third Affiliated hospital of Zhejiang Chinese Medical University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06223178 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of thumb-tack needle acupuncture as a treatment for Diminished Ovarian Reserve (DOR), a significant cause of infertility in women. The study will involve 106 female participants aged 18 to 40, who will be randomly assigned to receive either the thumb-tack needle treatment or a sham treatment in a 1:1 ratio. Over a period of 20 weeks, participants will undergo 12 sessions of treatment, with both patients and assessors blinded to group assignments. The primary aim is to evaluate the effectiveness of this novel acupuncture technique in improving ovarian reserve.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 40 with a clinical diagnosis of Diminished Ovarian Reserve.
Not a fit: Patients who are pregnant, breastfeeding, or have severe underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for women struggling with infertility due to diminished ovarian reserve.
How similar studies have performed: While acupuncture has been widely studied for infertility, the specific use of thumb-tack needles in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years old ≤ age \< 40 years old, female; * Clinical diagnosis of Diminished Ovarian Reserve: meet both items in twice tests with an interval of at least 4 weeks(tested between 2rd to 4th day of menstrual cycle): 1. 10 IU/L \< FSH \< 20 IU/L, 2. Anti-Müllerian hormone(AMH) \< 1.1ng/mL. * without any mind disease, willing to participate in the study and sign the informed consent. * without any other treatment. Exclusion Criteria: * Low or no response to exogenous gonadotropins, or with congenital anomalies in the development of the reproductive tract； * Pregnant or breastfeeding; * Abnormal body temperatures at the moment; * Psychopath, alcoholic, Patient with severe depression, history of substance abuse and severe primary diseases of cardiovascular, liver, kidney and hematopoietic system; * Currently enrolled in other clinical trials or refuse to cooperate with the study protocol.
Where this trial is running
Hangzhou, Zhejiang
- the Third affiliated hospital of Zhejiang Chinese Medical university — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Principal investigator: Xiaomei Shao, Ph.D — The Third Affiliated hospital of Zhejiang Chinese Medical University
- Study coordinator: Xiaomei Shao, Ph.D
- Email: shaoxiaomei@zcmu.edu.cn
- Phone: +8618957130287
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.
Conditions: Diminished Ovarian Reserve, Acupoint, Thumb-tack Needle, Randomized Controlled Trial