NCT06064669 Effect of Metformin on Healthy Live Birth in Women With Prediabetes
| NCT ID | NCT06064669 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shandong University |
| Condition | Metformin |
| Study Type | INTERVENTIONAL |
| Enrollment | 988 participants |
| Start Date | 2024-02-22 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 988 participants in total. It began in 2024-02-22 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.
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.
Contact & Investigator
Zi-Jiang Chen, Professor
PRINCIPAL INVESTIGATOR
Shandong University
Frequently Asked Questions
Who can join the NCT06064669 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 40 Years, studying Metformin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06064669 currently recruiting?
Yes, NCT06064669 is actively recruiting participants. Contact the research team at chenzijiang@vip.163.com for enrollment information.
Where is the NCT06064669 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06064669 clinical trial?
NCT06064669 is sponsored by Shandong University. The principal investigator is Zi-Jiang Chen, Professor at Shandong University. The trial plans to enroll 988 participants.