Effect of Metformin on Healthy Live Birth in Women With Prediabetes
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Metformin, Prediabetes, In-Vitro Fertilization
In brief
To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.
Key facts
- Study ID
- NCT06064669
- Run by
- Shandong University
- People needed
- 988
- Starts
- 2024-02-22
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2024-05-29
Who can join
Age: 20 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Women with a diagnosis of adenomyosis.
- Women with untreated hydrosalpinx.
- Women who plan to undergo PGT-SR or PGT-M.
- Women with major medical comorbidities, such as known liver disease, known renal disease, or known significant anemia.
Where it is running
- Shandong University — Jinan, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
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