Hydroxychloroquine plus levothyroxine for improving live birth in euthyroid women with recurrent pregnancy loss and TPO antibodies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter randomized trial comparing combined hydroxychloroquine (HCQ) plus levothyroxine (LT4) versus LT4 alone in euthyroid women who are positive for thyroid peroxidase antibodies and have unexplained recurrent pregnancy loss. Participants begin daily treatment at least eight weeks before attempting pregnancy and continue the assigned treatment through the end of pregnancy. Study visits occur at 4 and 8 weeks after treatment start, every 12 weeks before pregnancy, and during early pregnancy with additional phone follow-up; the primary outcome is live birth rate. The trial enrolls women aged 20–40 with negative antiphospholipid tests, normal couple karyotypes, and no uterine structural pathology.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Women with history of two or more pregnancy loss with the same male partner (including biochemical pregnancies).
2. Karyotype analyses show no pathological abnormalities in each individual of the recruited couple.
3. Women aged between 20 and 40 years old (including 20 and 40).
4. Lupus anticoagulant (LA), anticardiolipin antibody (ACA), and anti-beta2-glycoprotein I antibodies (anti-β2-GP1 Ab) tests are all negative.
5. It is confirmed by ultrasound or hysteroscopy that there are no pathological lesions that affect the morphology of the uterine cavity (such as submucosal uterine fibroids, uterine malformations).
6. TPO-Ab positive (TPO-Ab \> 60 IU/mL using the Siemens kit of electrochemiluminescence method, or TPO-Ab \> 34 IU/mL using the Roche kit of chemiluminescence method or other testing methods).
7. Biochemically euthyroid. TSH, free triiodothyronine (FT3), and free thyroxine (T4) are all within the reference range of corresponding laboratory testing in each research center.

Exclusion criteria:

1. Rheumatic diseases, such as systemic lupus erythematosus, undifferentiated connective tissue disease, etc.
2. Metabolic or endocrine diseases, such as diabetes.
3. Abnormal renal function: plasma creatinine level ≥130 μmol/L or abnormal liver function: alanine aminotransferase ≥80U/L or aspartate aminotransferase ≥80U/L.
4. Hypertension and malignant tumors.
5. Under treatment with glucocorticoids or immunosuppressor, including cyclosporine, azathioprine, prednisone, and methylprednisolone.
6. Body Mass Index (BMI) \>28kg/m2.
7. Past history of hyperthyroidism, hypothyroidism, and thyroid malignant tumors;
8. Allergy to 4-aminoquinoline compound, or those with retinal or visual field lesions caused by 4-aminoquinoline compound.

Where it's running

• Sun Yat-Sen Memorial Hospital
  Guangzhou, Guangdong, China Recruiting
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  Guangzhou, Guangdong, China Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.