Effect of Tiaojing Cuyun acupuncture on hypothalamic functional connectivity in patients with primary ovarian insufficiency based on multimodal functional magnetic resonance imaging
- Conditions
- Premature ovarian insufficiency
- Registration Number
- ITMCTR1900002486
- Lead Sponsor
- Jiangsu Provincial Traditional Chinese Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
The study will enroll patients with a diagnosis of POI who meets the following inclusion criteria:
(1) patients meeting the ESHRE Guideline diagnostic criteria for POI, right-handed;
(2) women between the ages of 18 and 40 years;
(3) and no acupuncture therapy within 2 months prior to study recruitment;
(4) sign the informed consent form and willing to participate in the study;
Patients meeting the following criteria will be selected as study volunteers:
(1) right-handed women between the ages of 18 and 40, age matched with POI patients;
(2) good health, no genetic history of familial psychosis, no claustrophobia;
(3) no metal substances in the body that affect functional magnetic resonance examination;
(4) not in pregnancy, postpartum lactation;
(5) sign the informed consent form and volunteer to participate in the study.
Patients meeting any of the following criteria will be excluded from the study:
1. abnormal development of congenital reproductive organs, or uterus, bilateral ovarian or bilateral salpingectomy, combined with severe primary diseases such as cardiovascular, renal, hepatic and hematopoietic systems;
2. endocrine diseases such as polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, hypothyroidism, and chronic adrenal insufficiency affect ovulation;
3. install a pacemaker, metal allergy or severe fear of the needle, claustrophobia;
4. mental or behavioral disorders that do not match the completion of clinical observations;
5. patients who are likely to be lost to follow-up according to the judgment of the investigator, such as patients whose work environment changes frequently, whose living environment is unstable;
6. who are participating in other drug clinical trials.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the hypothalamic functional connectivity imaging data obtained by fMRI;
- Secondary Outcome Measures
Name Time Method Pregnancy;Self-rating anxiety scale;Follicle stimulating hormone;prolactin;Testosterone;Antral follicle count;kupperman;Anti-müllerian hormone;Menstrual conditions;Estradiol;Luteinizing hormone;Progesterone;