CompletedNot Applicable

Effect of Thumbtack Needle (TN) on Ovarian Reserve Function of Women With Diminished Ovarian Reserve (DOR)

China240 participantsStarted 2021-10-18

Plain-language summary

Using a multi-center, large sample, randomized, patient-assessor blinded, sham-controlled clinical trial to evaluate the effect of thumbtack needle (TN) on ovarian function of patients with diminished ovarian reserve (DOR).

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluating the change of serum AMH level

Timeframe: 0 week and up to 4 weeks after treatment completion

Evaluating the change of the ovarian antral follicle count (AFC)

Timeframe: 0 week and up to 4 weeks after treatment completion

Trial details

NCT IDNCT05277948

SponsorDongmei Huang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-28

View on ClinicalTrials.gov More Diminished Ovarian Reserve trials