Polycystic ovary syndrome
Conditions
Interventions
Treatment group:Beinaglutide Injection
Sponsors
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of PCOS: Specific criteria are: Using the 2003 Rotterdam criteria, two of the following three criteria are met to diagnose PCOS: (1) Oligoovulation (defined as the interval between menstruations >= 35 days or the total number of menstrual periods in at least the last year = 12, or ovarian volume > 10 cm^3); (3) clinical manifestations of hyperandrogenism (hirsutism, acne) and/or biochemical characteristics of hyperandrogenism, excluding congenital adrenal hyperplasia, androgen-secreting tumors and Cushing's syndrome and other diseases caused by androgenism; 2. Patients with indications for IVF/ICSI-ET treatment: (1) Infertile patients who have not had contraceptive sex for at least 12 months and are not pregnant; (2) Combined with other infertility factors such as fallopian tube factors, male factors, advanced age, etc., or ineffective after other treatment options. 3.BMI >= 24 kg/m^2; 4. 18 years < age <=40 years; 5. Both husband and wife agree to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Having Type I or II diabetes; 2.Having uncontrollable hypertension (BP>160/100 mmHg); 3.Suffering from hypothalamic, pituitary, adrenal or thyroid diseases; 4.Suffering from severe cardiovascular, renal (estimated glomerular filtration rate, eGFR<60 mL/min/1.73 m^2) or liver disease (AST or ALT test values higher than 2.5 times the upper limit of normal, blood creatinine higher than 2 times the upper limit of normal); 5.Use of drugs known or suspected to affect insulin sensitivity, reproductive or metabolic function within the past 3 months (such as hormonal contraceptives, other steroid hormones, statins, and drugs that affect gastrointestinal motility or carbohydrate metabolism and/or anti obesity); 6.Having history of malignant tumors; 7.Undertaking weight loss treatment (weight loss greater than 5% in the past 3 months) or having a history of gastrointestinal surgery; 8.There are uterine abnormalities (untreated submucosal fibroids, intrauterine adhesions, uterine malformations, etc.), fallopian tube abnormalities (such as untreated hydrosalpinx), or ovarian pathology that may affect the outcome of assisted pregnancy; 9.Patients with a history or family history of medullary thyroid cancer and type 2 multiple endocrine neoplasia syndrome; 10.History of depression or a clear history of mental illness, such as depression, schizophrenia, and bipolar disorder; Use of antipsychotic or antidepressant drugs (clomipramine, amitriptyline, mirtazapine, paroxetine, phenethylamine, chlorpromazine hydrochloride, chlorpromazine, olanzapine, valeric acid and its derivatives, lithium preparations, thiamethoxam, etc.) within 3 months prior to screening; 11.Exposure to teratogenic doses of radiation, toxins, and drugs and being in the active period; 12.Individuals who are allergic or contraindicated to GLP-1 receptor agonists; 13.Drug use, alcohol or substance abuse, smokers; 14.Eating disorders (anorexia or bulimia) or clear gastrointestinal motility disorders or obstructive diseases (gastroparesis, gastroesophageal reflux disease);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical pregnancy rate; | — |
Countries
China
Contacts
Public ContactMiaoxin Chen
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Outcome results
None listed