Perimenopausal syndrome
Conditions
Interventions
Sponsors
Reproductive Hospital Affiliated to Jiangxi University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: Normal healthy women: 1. Healthy women with regular menstruation (menstrual cycle is 21-35 days, menstrual period is 2-7 days). 2. Age 20-40 years old. 3. Those who voluntarily take the test and sign the informed consent form. Patients with perimenopausal syndrome: 1. Select infertile women aged 20-40 (female factor infertility and female infertility due to male reasons), basic sex hormone levels: FSH: 3-10 mIU/ml, LH: 3-10 mIU/ml, E2: 10-70 pg/ml, AMH>=1.2 ng/ml, and the number of basal antral follicles is >7 pcs. 2. Comply with the IVF indications. 3. No unexplained abnormal uterine and vaginal bleeding. 4. Perimenopausal syndrome symptoms such as hot flashes, sweating, mood swings, insomnia, fatigue, bone and joint pain, etc., after the use of leuprolide, one or more symptoms appear, and these symptoms need to reach a certain severity and duration to meet the diagnostic criteria for perimenopausal syndrome. 5. Treatment history: no recent (such as in the past 6 months) has not used other hormonal drugs or treatments that may affect the results of the study. 6. Informed consent: Patients need to fully understand the content, purpose, risks and benefits of the study, and sign the informed consent form to express their willingness to participate in the study.
Exclusion criteria
Exclusion criteria: Normal healthy women exclusion criteria: 1. Menstrual disorders in the past two months. 2. Those who plan to become pregnant, pregnant, lactating, or lactating. 3. History of miscarriage in the past six months (medical abortion or surgical abortion). 4. Have taken medications such as antibiotics and contraceptives in the past month. 5. Female factor infertility and/or female infertility due to male reasons. 6. No major organ dysfunction and other serious diseases. 7. Those who are participating in other clinical trials. Patients with perimenopausal syndrome exclusion criteria: 1. Pregnant or lactating women should not be included in such studies. 2. Unexplained abnormal uterine and vaginal bleeding. 3. Premature ovarian failure caused by non-organic and postoperative surgery, and ovarian dysfunction caused by chromosomal abnormalities. 4. Dysfunction of important organs, such as heart, liver, kidney and other important organs with serious dysfunction, is excluded. 5. Patients with other endocrine disorders. 6. Use of antibiotics or oral probiotics within the last month. 7. Those who are allergic to gonadotropin-releasing hormone agonists (such as leuprolide) and excipients. 8. Other serious diseases: such as those with serious genetic, physical or mental diseases that are not suitable for pregnancy, as well as acute infectious diseases or sexually transmitted diseases of the genitourinary system, are not suitable for inclusion in the study. 9. Recent exposure to harmful substances: such as recent exposure to teratogenic amounts of radiation and toxic substances, or taking drugs and drugs with teratogenic effects and in the active period. 10. Other ineligible conditions: such as other specific exclusion conditions specified in the study design, such as specific types of endometriosis, specific degrees of menopausal syndrome symptoms, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perimenopausal Syndrome Scale;Hamilton Anxiety Measurement ;Hamilton Depression Measurement ;Athens Insomnia Scale;Sex hormone;Stool high-throughput sequencing; | — |
Countries
China
Contacts
Public ContactChen Weijun
Reproductive Hospital Affiliated to Jiangxi University of Traditional Chinese Medicine
Outcome results
None listed