Perimenopausal syndrome
Conditions
Interventions
Control group:For women with infertility who developed perimenopausal syndrome due to the administration of leuprorelin during the assisted reproductive process, they were treated with oral placebo fo
Experimental group:For infertile women who developed perimenopausal syndrome due to the administration of leuprorelin during the assisted reproductive process, oral probiotic treatment was administere
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: 1. Infertile women aged between 20 and 40 years old (including those with female-factor infertility or infertility caused by the partner), whose basal hormone levels before the suppression treatment should meet the following requirements: FSH between 3-10 mIU/ml, LH between 3-10 mIU/ml, E2 between 10-70 pg/ml, AMH no less than 1.2 ng/ml, and the total number of basal antral follicles in both ovaries should be more than 7. 2. Have the medical indications for in vitro fertilization (IVF) treatment. 3. Have no abnormal uterine bleeding or irregular vaginal bleeding with an unclear cause. 4. Show symptoms related to perimenopausal syndrome after using leuprorelin, such as hot flashes, night sweats, mood swings, sleep disorders, fatigue, joint pain, etc., with at least one or more of these symptoms present, and the severity and duration of the symptoms need to meet the corresponding clinical diagnostic requirements. 5. Treatment background: During the period before enrollment (for example, the last 6 months), no hormone-based drugs or other related treatments that may interfere with the study assessment were received. 6. Informed consent: The subjects have fully understood the research process, purpose, potential risks and benefits, and signed the informed consent form, voluntarily participating in this study.
Exclusion criteria
Exclusion criteria: 1. Women who are currently pregnant or breastfeeding are excluded from the study. 2. There is unexplained bleeding in the uterus or vagina. 3. Premature ovarian failure caused by non-surgical factors, or ovarian function decline due to chromosomal abnormalities. 4. Severe functional impairment of important organs such as the heart, liver, and kidneys. 5. Patients with other endocrine system diseases. 6. Those who have used antibiotics or oral probiotic preparations within the last month. 7. Have had an allergic reaction to gonadotropin-releasing hormone agonists (such as leuprorelin) or any component in their formulations. 8. Have other serious systemic diseases, including genetic disorders unsuitable for pregnancy, significant organ lesions, mental and psychological disorders, and active reproductive tract infections or sexually transmitted diseases. 9. Have recently been exposed to radiation with teratogenic risks, toxic chemicals, or taken drugs or drugs that may cause teratogenicity, and are still within the affected period. 10. Other specific exclusion conditions specified in the research protocol, such as specific types or degrees of endometriosis, or specific severe menopausal symptoms, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perimenopausal Syndrome Scale Score;Gut microbiota;Metabolite levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| Emotional scale score;Hormone levels; | — |
Countries
China
Contacts
Public ContactChen Weijun
Reproductive Hospital Affiliated to Jiangxi University of Traditional Chinese Medicine
Outcome results
None listed