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The Effects of Inositol and Metformin on Pregnancy Outcomes in Women with Insulin Resistance and History of Spontaneous Abortion: An Open-Label, Non-Inferiority, Prospective Randomized Controlled Trial

The Effects of Inositol and Metformin on Pregnancy Outcomes in Women with Insulin Resistance and History of Spontaneous Abortion: An Open-Label, Non-Inferiority, Prospective Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122348
Enrollment
Unknown
Registered
2026-04-13
Start date
2025-09-08
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous abortion

Interventions

The metformin group:Take metformin orally (twice a day, 0.5g each time)
The inositol group:Take oral inositol (once a day, 0.5g each time)

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. 20 years old 2.6) 4. Before being included in the study, no treatment with metformin or inositol was administered for one month 5. No plans for pregnancy in the coming month 6. Sign the informed consent form

Exclusion criteria

Exclusion criteria: 1.Systemic infectious diseases; 2.Congenital uterine malformations (such as single-lobed uterus, double-lobed uterus, septate uterus, etc.); 3.Uncontrolled endocrine disorders; 4.Uncontrolled autoimmune diseases; 5.Abnormal liver function (bilirubin > 16 µmol/L, ALT > 60 IU/L) or abnormal kidney function (urea > 6.6 mmol/L, creatinine > 85 µmol/L, sodium > 145 mmol/L, potassium > 5.0 mmol/L);

Design outcomes

Primary

MeasureTime frame
Early miscarriage rate;

Secondary

MeasureTime frame
HOMA-IR;Incidence of adverse reactions;BMI;Incidence of Common Pregnancy Complications;Delivery Outcomes;

Countries

China

Contacts

Public ContactHui Chen

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

zheling76@163.com+86 20 8133 2587

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026