Effect of Metformin on Healthy Live Birth in Women With Prediabetes

• Status: Not yet recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shandong University
• Collaborators: General Hospital of Ningxia Medical University; Maternal and Child Health Hospital of Henan Province; Qingdao women's and children's Hospital; Ren Ji Hospital of Shanghai Jiao Tong University; Shengjing Hospital; West China Second University Hospital; Women's Hospital of Nanjing Medical University; Women's Hospital of Zhejiang University
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. Women who are diagnosed with prediabetes by ADA criteria, including either IFG, IGT, or HbA1C 5.7-6.4%.

2. Women aged 20-40 years.

3. Women who plan to undergo a new cycle of IVF, ICSI, or PGT-A.

Exclusion Criteria:

1. 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.

2. 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.

3. Women with un-corrected hyperthyroidism or hypothyroidism.

4. Women with congenital or acquired abnormal uterine cavity including septate uterus, unicornous uterus, uterus duplex, and intrauterine adhesions.

5. Women with a diagnosis of adenomyosis.

6. Women with untreated hydrosalpinx.

7. Women who plan to undergo PGT-SR or PGT-M.

8. Women with major medical comorbidities, such as known liver disease, known renal disease, or known significant anemia.