Effect of Metformin on Healthy Live Birth in Women With Prediabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorShandong University

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

988 Participants
are divided into 4 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