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Clinical Trials in China / NCT06064669
Recruiting Not applicable

Effect of Metformin on Healthy Live Birth in Women With Prediabetes

NCT06064669 · tracked via the Priya Life Science China tracker
Sponsor
Shandong University
Phase
Not applicable
Started
2024-02-22
Last updated
2024-05-29

Condition(s) studied

MetforminPrediabetesIn-Vitro Fertilization

Investigational drug(s) / intervention(s)

Metformin pretreatment before ovarian stimulationPlacebo pretreatment before ovarian stimulationMetformin pretreatment before endometrial preparation for frozen embryo transferPlacebo pretreatment before endometrial preparation for frozen embryo transfer

Metformin pretreatment before ovarian stimulation: The enrolled patients will be prescribed metformin 850mg twice daily for at least 4 weeks prior to ovarian stimulation till oocyte retrieval.

Placebo pretreatment before ovarian stimulation: The enrolled patients will be prescribed placebo 850mg twice daily for at least 4 weeks prior to ovarian stimulation till oocyte retrieval.

Metformin pretreatment before endometrial preparation for frozen embryo transfer: After oocyte retrieval, the enrolled patients will be prescribed metformin 850mg twice daily for at least 4 weeks before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer.

Placebo pretreatment before endometrial preparation for frozen embryo transfer: After oocyte retrieval, the enrolled patients will be prescribed placebo 850mg twice daily for at least 4 weeks before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer.

Study summary

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

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
40 Years
Healthy 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.

Primary outcome measure(s)

  • healthy live birth — From the date of randomization until delivery after the first embryo transfer, up to 16 months
    defined as a singleton live birth at ≥37 weeks, with infant birth weight between 2500 and 4000g and without a major congenital anomaly.

Trial sites (1)

FacilityCityRegionStatus
Shandong University Jinan Shandong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06064669 on ClinicalTrials.gov ↗ ← All trials in China