Using Metformin to Improve Live Birth Rates in Women with Prediabetes Undergoing IVF

Effect of Metformin on Healthy Live Birth After In-vitro Fertilization in Women With Prediabetes Mellitus: a Multicenter Double-blind Placebo Controlled Randomized Trial

This study is testing if taking metformin before IVF can help women with prediabetes have a healthier chance of getting pregnant and having a baby.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 988 (estimated)
• Ages: 20 Years to 40 Years
• Sex: Female
• Sponsor: Shandong University (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06064669 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women diagnosed with prediabetes. It aims to determine whether starting metformin before ovarian stimulation or before frozen embryo transfer can enhance the chances of achieving a healthy live birth compared to a placebo. The study involves administering metformin or placebo to participants and monitoring their reproductive outcomes during in-vitro fertilization procedures.

Who should consider this trial

Good fit: Ideal candidates are women aged 20-40 with a diagnosis of prediabetes who plan to undergo a new cycle of IVF, ICSI, or PGT-A.

Not a fit: Patients diagnosed with diabetes or those taking medications that interfere with glucose metabolism will not benefit from this study.

Why it matters

Potential benefit: If successful, this could significantly increase the likelihood of healthy live births for women with prediabetes undergoing IVF.

How similar studies have performed: Other studies have shown promising results with metformin in improving reproductive outcomes, suggesting potential success for this approach.

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.

Where this trial is running

Jinan, Shandong

• Shandong University — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Zi-Jiang Chen, Professor — Shandong University
• Study coordinator: Zi-Jiang Chen, Professor

Conditions Metformin; Prediabetes; In-Vitro Fertilization