Effect of Metformin on Healthy Live Birth in Women With Prediabetes

Launched by SHANDONG UNIVERSITY · Sep 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called metformin may help women with prediabetes who are trying to achieve a healthy pregnancy through in-vitro fertilization (IVF). Prediabetes means that a person's blood sugar levels are higher than normal but not high enough to be classified as diabetes. The goal of the trial is to see if taking metformin before starting IVF can improve the chances of having a healthy live birth.

To participate in the trial, women need to be between the ages of 20 and 40 and must have been diagnosed with prediabetes. They should also be planning to start a new cycle of IVF, which is a process that helps women get pregnant. However, there are some health conditions that would exclude someone from joining, such as having diabetes or certain other medical issues. If you decide to participate, you will be monitored throughout the study to assess how metformin affects your reproductive outcomes. This trial is currently looking for participants, so if you think you might qualify, it could be a good opportunity to consider.

Gender

FEMALE

Eligibility 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.