RecruitingNot Applicable

Effect of Metformin on Healthy Live Birth in Women With Prediabetes

China988 participantsStarted 2024-02-22

Plain-language summary

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

Age range20 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

healthy live birth

Timeframe: From the date of randomization until delivery after the first embryo transfer, up to 16 months

NCT IDNCT06064669

SponsorShandong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Zi-Jiang Chen, Professor

Who can participate

Age range20 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.