Infertility
Conditions
Interventions
The control group:Routine body weight management and metformin treatment
The semaglutide group:Routine body weight management and the combination treatment of semaglutide and metformin
Sponsors
PLA Strategic Support Force Medical Center
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1)Females with clinically diagnosed infertility; (2)Body mass index >= 24kg/m^2; (3)Females who plan to conceive and voluntarily participate in this trial with informed oral and written consent;
Exclusion criteria
Exclusion criteria: (1) Infertility caused by organic factors or male factors; (2) Use of weight-lowering medications or glucagon like peptide (GLP-1) drugs within the preceding 3 months; (3) Use of medications that may lead to clinically significant weight gain within the preceding 3 months; (4) Use of medications that affect sex hormone levels within the preceding 3 months; (5) Allergy to any of the ingredients of the study medication or other GLP-1 RA drugs; (6) A family or a personal history of multiple endocrine neoplasia syndrome type 2 (MEN 2); (7) A family or a personal history of medullary thyroid carcinoma (MTC); (8) A history of acute and chronic pancreatitis; (9) Psychiatric disease, such as depression, schizophrenia, bipolar disorder; (10) A history of carcinoma; (11) Severe cardiovascular disease, severe hepatic impairment, or severe renal impairment; (12) Type 1 diabetes or type 2 diabetes; (13) Fasting blood glucose level >= 7.0 mmol/L, 2h-postprandial blood glucose level >= 11.1 mmol/L; (14) Congenital adrenal hyperplasia, Cushing's syndrome; (15) Unable to take effective contraceptive measures during the trial; (16) Unable to understand the experimental requirements; (17) Any condition that the investigator feels would interfere with trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in menstrual frequency (number of menstruation / months) from baseline to week 12;The change in follicle stimulating hormone (FSH) levels from baseline to week 12;The change in weight from baseline to week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of subjects whose body weight decreased = 5% from baseline to week 12;The percentage of subjects whose body weight decreased = 10% from baseline to week 12;Sinus follicle count;Anti-mullerian hormone ;Luteinizing hormone;Estradiol;Testosterone;Progesterone ;Follicle stimulating hormone/luteinizing hormone;Clinical pregnancy rate;HOMA-IR;Fasting blood glucose;2h postprandial blood glucose;Fasting insulin;Fasting C-peptide ;2h postprandial insulin;2h postprandial C-peptide;Triglyceride;Total cholesterol;Low density lipoprotein cholesterol;High density lipoprotein cholesterol;Lipase;Amylase;Adiponectin;Leptin;Well-being index scale score;Generalized anxiety disorder scale score;Depression screening scale score;Eating habit; | — |
Countries
China
Contacts
Public ContactWang Aihong
PLA Strategic Support Force Medical Center
Outcome results
None listed