Diminished Ovarian Reserve (DOR)
Conditions
Brief summary
This study will include 246 patients with ovarian reserve dysfunction (DOR), who will be randomly divided into a treatment group and a control group, with 123 patients in each group. The treatment group will receive electro-thumbtack needle treatment, while the control group will receive placebo electro-thumbtack needle treatment. Both groups will receive a treatment course of 3 menstrual cycles. This study evaluates the effect of electrocautery on the live birth rate of patients with DOR.
Interventions
OTHERelectro-thumbtack needle
The treatment acupoints include bilateral ovarian acupoints, Guan Yuan (CV4), bilateral Shen Shu (BL23), bilateral waist and eye acupoints (EX-B7), bilateral San Yin Jiao (SP6), and bilateral Zu San Li (ST36), totaling 11 acupoints. Among them, the bilateral ovarian acupoints and bilateral waist eye acupoints (EX-B7) were treated with electro-thumbtack needle. Other acupoints were treated with thumbtack needle.Choose a sparse and dense waveform, adjust the intensity to the maximum patient can tolerate, and stimulate for 30 minutes each time. After the stimulation is completed, remove the electrode patch and electroacupuncture device, and keep the electric needle at the acupoint for another 3 days.During the needle retention period, the electric needles at the bilateral ovarian acupoints and bilateral waist and eye acupoints were alternately stimulated once every other day using an electroacupuncture device for 30 minutes each time.
OTHERplacebo electro-thumbtack needle
The control group selected acupoints that were the same as the treatment group. Bilateral ovarian acupoints and bilateral waist and eye acupoints are treated with placebo electro-thumbtack needle, while other acupoints are treated with placebo electro-thumbtack needle. The treatment methods for placebo electro-thumbtack needle and placebo thumbtack needle are the same as those for the treatment group.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* The age range is 18-40 years old; * Meets the diagnostic criteria for DOR as follows: ① AMH\<1.1 ng/ml; ② 10 U/L \< FSH \< 25U/L or FSH/LH \> 3.6; ③ The total number of follicles (AFC) in both basal sinuses is less than 7. If any two of the above criteria (①②③) are met, it can be diagnosed as DOR. * At least one side of the patient's fallopian tube is unobstructed; * The semen routine examination of the patient's spouse is normal; * Voluntarily sign the informed consent form.
Exclusion criteria
* Chromosomal or genetic abnormalities in either the female or male partner; * Women with blocked fallopian tubes on both sides; * Have a history of ovarian surgery, such as ovarian teratoma or ovarian chocolate cyst surgery; * The female party suffers from uncorrected endocrine disorders such as simple hyperthyroidism or hypothyroidism, hyperprolactinemia, and pancreatic islet dysfunction; * Hormone resistance, diabetes, adrenal diseases, etc; * The woman has a clearly diagnosed autoimmune disease such as systemic lupus erythematosus, rheumatoid arthritis; * Antiphospholipid syndrome, Sjogren's syndrome, Hashimoto's thyroiditis, etc; * The female or male partner has a history of malignant tumors and has received treatment with radiotherapy and chemotherapy; * The woman has received acupuncture and moxibustion or press acupuncture treatment in recent 3 months; * Those who take traditional Chinese medicine decoctions or granules during treatment; * Men with abnormal semen examination; * Clear diagnosis of moderate or severe adenomyosis; * Clearly diagnose uterine fibroids with a diameter greater than 5cm; * I do not agree to sign the informed consent form for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| live birth rate | 3 months | The live birth rate is defined as the proportion of live births after 28 weeks of pregnancy, usually calculated by dividing the number of live birth cycles by the total number of patients and multiplying by 100%. This indicator is commonly used to evaluate the effectiveness of reproductive health centers or specific treatment methods, reflecting the ultimate outcome of successful pregnancy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical pregnancy rate | 3 months | Biochemical pregnancy, also known as subclinical miscarriage or occult miscarriage, refers to the phenomenon where the embryo fails to successfully implant on the uterine wall in the early stages, leading to termination of pregnancy.The biochemical pregnancy rate is calculated by dividing the number of biochemical pregnancies by the total number of patients. |
| clinical pregnancy rate | 3 months | Clinical pregnancy refers to the presence of a gestational sac in the uterine cavity, as well as the appearance of fetal buds and primitive heartbeats, observed through ultrasound examination in the early stages of pregnancy. These signs indicate normal implantation and development of the embryo, confirming a normal intrauterine pregnancy.The clinical pregnancy rate is calculated by dividing the number of pregnancies by the total number of patients. |
| Threatened miscarriage rate | 3 months | Threatened miscarriage refers to symptoms such as vaginal bleeding and abdominal pain that occur before 28 weeks of pregnancy, but at this time the cervix is not open, the membranes are intact, there is no discharge of pregnancy material, and the size of the uterus matches the gestational age. The threatened miscarriage rate is calculated by dividing the number of threatened miscarriages by the total number of patients. |
| abortion rate | 3 months | The miscarriage rate is calculated by dividing the number of miscarriages by the total number of patients. |
| Anti Mullerian hormone (AMH) | 3 months | Anti Mullerian hormone (AMH) is a glycoprotein hormone secreted by follicular granulosa cells in the ovary. It is of great significance in evaluating women's ovarian reserve function and can be used to assess the number and quality of follicles in the ovaries. The concentration of AMH in serum will be measured. |
| Antral Follicle Count (AFC) | 3 months | Antral Follicle Count (AFC) refers to the count of antral follicles present in the ovary using ultrasound technology. Sinus follicles are small follicles with a diameter of approximately 2-9mm located in the ovary. These follicles are in the early developmental stage of the cycle and have a good correlation with women's ovarian reserve function |
| follicle stimulating hormone（FSH） | 3 months | The concentration of follicle stimulating hormone（FSH） in serum will be measured. The changes in FSH levels can reflect ovarian function and ovulation status, and are of great significance for the diagnosis and monitoring of various gynecological diseases.FSH was measured on the second day of menstruation. |
| Luteinizing hormone (LH) | 3 months | The concentration of Luteinizing hormone (LH) in serum will be measured. LH is a glycoprotein hormone secreted by pituitary cells, mainly acting on mature oocytes, which can induce ovulation and produce corpus luteum.LH is measured on the second day of menstruation. |
| estradiol（E2） | 3 months | The concentration of estradiol（E2） in serum will be measured.The level of estradiol is commonly used to assess the reproductive health status of women, which is measured on the second day of menstruation. |
| Progesterone（P） | 3 months | The concentration of Progesterone（P） in serum will be measured.Progesterone is an important progesterone mainly secreted by the corpus luteum of the ovary and also present in the adrenal cortex and placenta. Progesterone plays a crucial role in the female reproductive system, including maintaining normal menstrual cycles, promoting endometrial development, providing a suitable implantation environment for fertilized eggs, and maintaining pregnancy. |
| Prolactin（PRL） | 3 months | The concentration of Prolactin（PRL） in serum will be measured.Prolactin also affects female reproductive function, such as follicle development and ovulation process |
| Testosterone（T） | 3 months | The concentration of Testosterone（T） in serum will be measured.Testosterone is a steroid hormone mainly secreted by the testicles of males and ovaries of females |
| Zung Self-rating depression scale(Zung-SDS) | 3 months | Zung SDS is mainly used to evaluate the severity and changes of individual depressive symptoms.Composed of 20 questions, the scores of each of the 20 items are added together to obtain a rough score. The standard score is equal to the integer part obtained by multiplying the coarse score by 1.25. The normal upper limit of the total gross score is 41 points, and the standard total score is 53 points. |
| Short form-36（SF-36） | 3 months | SF-36， The Medical Outcomes Study - Short Form, also known as the Health Survey Short Form, is a universal measurement scale developed from the Boston Health Study in the United States. This scale consists of 36 items and is evaluated.The score range of SF-36 scale is 0-100 points, where 100 points represents the best health status and 0 points represents the worst health status. |
| Chinese Quality of Life Scale (CHQOL) | 3 months | The Chinese Quality of Life Scale (CHQOL) is a new universal scale developed based on the concept of traditional Chinese medicine health, which is used for evaluation.Full score of 60, the higher the score, the higher the quality of life. |
| Self Rating Sleep Scale (SRSS) | 3 months | SRSS is a tool used to screen and evaluate individual sleep problems. It consists of 10 items, each rated on a 5-point scale, with higher scores indicating more severe sleep problems. The scoring criteria for the SRSS are as follows: 10 items are rated on a scale of 1-5, with a total score range of 10-50 points. The higher the score, the more severe the sleep problem. |
| The Sleep Disorders Rating Scale (SDRS) | 3 months | The Sleep Disorders Rating Scale (SDRS) is a tool used to assess an individual's sleep status over the past week.Each item has a maximum score of 3 points, and the total score can reach up to 21 points. The higher the score, the more severe the sleep disorder. |
| Pittsburgh Sleep Quality Index (PSQI) | 3 months | The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-assessment scale used to evaluate an individual's sleep quality over the past month.The total score range of the scale is 0-21 points, with higher scores indicating poorer sleep quality. |
| corticotropin releasing hormone (CRH) | 3 months | The concentration of CRH in serum will be measured.Corticotropin releasing hormone (CRH) is a forty one peptide hormone secreted by the hypothalamus. Its main function is to promote the synthesis and release of adrenocorticotropic hormone (ACTH) by the pituitary gland, thereby regulating the secretion of glucocorticoids by the adrenal cortex |
| norepinephrine | 3 month | The concentration of norepinephrine in serum will be measured. |
| epinephrine | 3 months | The concentration of epinephrine in serum will be measured. |
| 5-hydroxytryptamine (5-HT) | 3 months | The concentration of 5-hydroxytryptamine (5-HT) in serum will be measured. |
| gamma aminobutyric acid (GABA) | 3 months | The concentration of gamma aminobutyric acid (GABA) in serum will be measured. |
| dopamine (DA) | 3 months | The concentration of dopamine (DA) in serum will be measured. |
| beta endorphin (β - ET) | 3 months | The concentration of beta endorphin (β - ET) in serum will be measured. |
| ZungSelf-RatingAnxietyScale（Zung-SAS） | 3 months | Zung SAS is mainly used to evaluate an individual's anxiety symptoms and their severity.The total score range of this scale is 20 to 80 points. After conversion, the score can be used as an indicator of anxiety level - usually multiplying the original score by 1.25 and converting it into a norm score. The higher the norm score, the more severe the individual's anxiety level. |
Outcome results
None listed