About this trial
To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.
Eligibility criteria
Qualifiers
Women who are diagnosed with prediabetes by ADA criteria, including either IFG, IGT, or HbA1C 5.7-6.4%.
Women aged 20-40 years.
Women who plan to undergo a new cycle of IVF, ICSI, or PGT-A.
Disqualifiers
Women who are diagnosed with diabetes according to the ADA criteria11,12, which is meeting one of the following criteria: fasting plasma glucose ≥7.0mmol/L, 2-h plasma glucose during 75-g OGTT ≥11.1mmol/L, HbA1c≥6.5%, or a random plasma glucose≥11.1mmol/L.
Women who are taking medicine that interfere with glucose metabolism, such as metformin, oral anti-diabetic agents (sulfonylureas, glinides, thiazolidinediones, α-glycosidase inhibitors, GLP-1 receptor agonist, etc.), weight loss drugs (i.e.orlistat, etc.), glucocorticoids, and growth hormones within 2 months before enrollment.
Women with un-corrected hyperthyroidism or hypothyroidism.
Women with congenital or acquired abnormal uterine cavity including septate uterus, unicornous uterus, uterus duplex, and intrauterine adhesions.
Trial design
Treatments tested in this trial
- Metformin pretreatment before ovarian stimulation
- Placebo pretreatment before ovarian stimulation
- Metformin pretreatment before endometrial preparation for frozen embryo transfer
- Placebo pretreatment before endometrial preparation for frozen embryo transfer
Treatment groups
Sponsors and collaborators
Shandong University
Lead sponsor
Ren Ji Hospital of Shanghai Jiao Tong University
Collaborator
Women's Hospital of Zhejiang University
Collaborator
Shengjing Hospital
Collaborator
Nanjing Medical University
Collaborator
General Hospital of Ningxia Medical University
Collaborator
West China Second University Hospital
Collaborator
Henan Provincial Maternal and Child Health Care Hospital
Collaborator
Qingdao women's and children's Hospital
Collaborator