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Could a common arthritis drug help prevent miscarriages?

NCT ID NCT06652113

Disease control Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether adding hydroxychloroquine (an anti-inflammatory drug) to levothyroxine (a thyroid hormone) can increase live birth rates in women with thyroid antibodies and unexplained recurrent pregnancy loss. About 800 women will take either the combination or levothyroxine alone, starting at least 8 weeks before pregnancy and continuing through pregnancy. The main goal is to see if more women in the combination group give birth after 28 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hydroxychloroquine and levothyroxine
What this could lead to
If successful, this could offer a new treatment option to help women with thyroid antibodies and unexplained recurrent pregnancy loss have a live birth.
What could go wrong
This is a mid-stage trial, so results are not guaranteed. The combination may not improve outcomes over levothyroxine alone, and hydroxychloroquine can have side effects like vision problems or heart issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 796 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Mar 2037

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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). 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.

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Conditions

The condition(s) this trial relates to.

pregnancy loss, recurrent, 4 pregnancy loss, recurrent, susceptibility

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Euthyroid with thyroid antibodies Recurrent pregnancy loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sun Yat-Sen Memorial Hospital

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510120, China

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