Effect of Thumbtack Needle (TN) on Ovarian Reserve Function of Women With Diminished Ovarian Rese… (NCT05277948) | Clinical Trial Compass
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 range18 Years – 40 Years
SexFEMALE
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.
What they're measuring
1
Evaluating the change of serum AMH level
Timeframe: 0 week and up to 4 weeks after treatment completion
2
Evaluating the change of the ovarian antral follicle count (AFC)
Timeframe: 0 week and up to 4 weeks after treatment completion