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Effect of Metformin on Healthy Live Birth in Women With Prediabetes
RECRUITINGN/ASponsored by Shandong University
Actively Recruiting
PhaseN/A
SponsorShandong University
Started2024-02-22
Est. completion2026-12-31
Eligibility
Age20 Years – 40 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06064669
Summary
To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.
Eligibility
Age: 20 Years – 40 YearsSex: FEMALEHealthy volunteers accepted
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.
Conditions4
DiabetesIn-Vitro FertilizationMetforminPreDiabetes
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Actively Recruiting
PhaseN/A
SponsorShandong University
Started2024-02-22
Est. completion2026-12-31
Eligibility
Age20 Years – 40 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06064669