Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Effect van HCQ gecombineerd met LT4 op LBR bij euthyroïde vrouwen met URPL en TPO-Ab (QT-LIFE)

27 september 2026 bijgewerkt door: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

De werkzaamheid van hydroxychloroquine in combinatie met levothyroxine bij euthyroïde vrouwen met schildklierantistoffen Positief en onverklaard terugkerend zwangerschapsverlies: een multicenter, gerandomiseerde gecontroleerde studie

The goal of this clinical trial is to learn if combined treatment of levothyroxine and hydroxychloroquine would improve the live birth of euthyroid women with thyroid peroxidase antibodies and unexplained recurrent pregnancy loss.

Researchers will compare combined treatment of levothyroxine and hydroxychloroquine to a treatment of levothyroxine alone to see if combined treatment works to improve live birth of euthyroid participants with thyroid peroxidase antibodies and unexplained recurrent pregnancy loss.

Participants will:

  • Receive combined treatment of levothyroxine and hydroxychloroquine or treatment of levothyroxine alone every day at least 8 weeks before pregnancy, and continue their treatment till the end of pregnancy.
  • Visit the clinic 4 weeks and 8 weeks after their treatments, and every 12 weeks before they get pregnant for checkups and tests. During their pregnancy, they will visit the clinic before gestation of 12 weeks, and will be followed up with phone call in the second trimester and after parturition.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Thyroid peroxidase antibodies (TPO-Ab) in euthyroid women are associated with recurrent pregnancy loss. According to 2017 Guidelines of the American Thyroid Association, administration of levothyroxine (LT4) to TPO-Ab-positive euthyroid pregnant women with a prior history of loss may be considered given its potential benefits in comparison with its minimal risk. However, it is a weak recommendation with low-quality evidence. Recently published randomised clinical trials showed that administration of LT4 does not improve pregnancy outcomes of euthyroid thyroid peroxidase antibody positive women with recurrent pregnancy loss. Published data showed TPO-Ab is related to immune imbalance. Hydroxychloroquine is a widely used immune modulator even in fields of autoimmune disorders during pregnancy and lactation. Nevertheless, the effect of hydroxychloroquine combined with LT4 on live birth rate of euthyroid women with TPO-Ab and unexplained recurrent pregnancy loss is unclear. Therefore, we designed a multicenter RCT to verify the study hypothesis that combined treatment of levothyroxine and hydroxychloroquine would improve the live birth rate of euthyroid women with thyroid peroxidase antibodies and unexplained recurrent pregnancy loss.

Studietype

Ingrijpend

Inschrijving (Geschat)

796

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
      • Guangzhou, Guangdong, China, 510000
        • Werving
        • Sun Yat-Sen Memorial Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 40 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: hydroxychloroquine and levothyroxine group

Corresponding oral treatment will be initiated after randomization and preconceptually, and continue to the end of pregnancy or until 60 weeks post-randomisation if pregnancy does not occur. Patients in the experimental group will be given a combined oral treatment of hydroxychloroquine (HCQ) and levothyroxine. Hydroxychloroquine sulfate tablets will be given at a total daily dose of 0.2g to 0.4g based on individual weight: patients weighing ≤46kg take HCQ tablets 0.2g/d, patients weighing >46kg and <62kg take HCQ tablets 0.3g/d, patients weighing ≥62kg take HCQ tablets 0.4g/d. Levothyroxine sodium tablets (Euthyrox, 50 μg) will be given 12.5μg ~50 μg daily based on patients' TSH levels and weights: TSH ≥ 2.5 mIU/L, the dosage is 50 μg/d; TSH < 2.5 mIU/L, the dosage is 25 μg/d; when the patient's weight is less than 50kg, the dosage is reduced by 50%.
Geneesmiddel: hydroxychloroquine and levothyroxine

Hydroxychloroquine sulfate tablets will be given at a total daily dose of 0.2g to 0.4g based on individual weight as described above. During the study, if TSH is higher than 4.0 mIU/L or exceeds the lower limit of the reference range of the center in the first trimester, or TSH level exceeds the normal range of the center during the second or the third trimester, subjects will be instructed to suspend the medication and visit the Department of Endocrinology.
Ander: levothyroxine group

Corresponding oral treatment will be initiated after randomization and preconceptually, and continued to the end of any pregnancy or until 60 weeks post-randomisation if pregnancy does not occur. Patients assigned in the control group will be given levothyroxine daily. Levothyroxine sodium tablets will be given 12.5μg ~50 μg daily based on patients' TSH levels and weights: TSH ≥ 2.5 mIU/L, the dosage is 50 μg/d; TSH < 2.5 mIU/L, the dosage is 25 μg/d; when the patient's weight is less than 50kg, the dosage is reduced by 50%.
Geneesmiddel: Levothyroxine

Levothyroxine sodium tablets (Euthyrox, 50 μg) will be given 12.5μg ~50 μg daily based on patients' TSH levels and weights as described above. During the study, if TSH is higher than 4.0 mIU/L or exceeds the lower limit of the reference range of the center in the first trimester, or TSH level exceeds the normal range of the center during the second or the third trimester, subjects will be instructed to suspend the medication and visit the Department of Endocrinology.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Birth of a living child beyond 28 weeks
Tijdsspanne: After birth, within 24 months after randomization

The primary outcome is the proportion of women with a live birth at or beyond 28 completed weeks. This proportion will be calculated with the denominator totalling all women randomised, and the numerator (i.e., treatment successes) totalling women who conceive within 60 weeks of randomisation and go on to give live birth at or beyond 28 weeks gestation.
After birth, within 24 months after randomization

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinical pregnancy at 5 to 8 weeks
Tijdsspanne: At 5-8 weeks of pregnancy

It is the proportion of women with a cardiac activity confirmed by ultrasound during 5 to 8 weeks of gestation. This proportion will be calculated with the denominator totalling all women randomised, and the numerator totalling women who have clinical pregnancy within 60 weeks of randomisation.
At 5-8 weeks of pregnancy
Miscarriage <28 weeks
Tijdsspanne: At 28 weeks of pregnancy

Miscarriage that occurs less than 28 weeks of gestation
At 28 weeks of pregnancy
Gestation at miscarriage, weeks
Tijdsspanne: After the time of miscarriage, within 24 months after eligibility

Gestation at miscarriage, weeks
After the time of miscarriage, within 24 months after eligibility
On-going pregnancy at 12 weeks
Tijdsspanne: At 12 weeks of pregnancy

On-going pregnancy at 12 weeks
At 12 weeks of pregnancy
Gestation at delivery >34 weeks/>37 weeks
Tijdsspanne: After birth, within 24 months after eligibility

Number of women who have a delivery at least 34 weeks of gestation. Number of women who have a delivery at least 37 weeks of gestation.
After birth, within 24 months after eligibility
Gestation at delivery, weeks
Tijdsspanne: After birth, within 24 months after eligibility

Gestation at delivery, weeks
After birth, within 24 months after eligibility
Birth weight, grams
Tijdsspanne: At birth, within 24 months after eligibility

Birth weight, grams
At birth, within 24 months after eligibility
APGAR score at 1 minute/5 minutes
Tijdsspanne: After birth, within 24 months after eligibility

APGAR score at 1 minute/5 minutes of the neonates.
After birth, within 24 months after eligibility
birth defects
Tijdsspanne: At or short after birth, within 24 months after eligibility

Birth defects of the neonates.
At or short after birth, within 24 months after eligibility
Maternal antenatal complications,intrapartum complications,maternal postnatal complications
Tijdsspanne: up to birth/immediately after delivery

Hypertensive disorders of pregnancy, gestational diabetes, placenta previa, placental abruption, polyhydramnios, oligohydramnios, fetal growth restriction, postpartum hemorrhage and so on.
up to birth/immediately after delivery
Time to pregnancy.
Tijdsspanne: At 5-8 weeks of pregnancy

It refers to the time interval from patients trying to prepare for pregnancy (after 8 weeks of medication) to successful pregnancy (intrauterine pregnancy confirmed by ultrasound).
At 5-8 weeks of pregnancy
live birth rate after at least 28 weeks of gestation among pregnant patients
Tijdsspanne: After birth, within 24 months after randomization

It is the proportion of women with a live birth at or beyond 28 of completed weeks. This proportion will be calculated with the denominator totalling all women who have clinical pregnancy within 60 weeks of randomisation, and the numerator totalling women who have a live birth at or beyond 28 of completed weeks.
After birth, within 24 months after randomization

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 november 2024

Primaire voltooiing (Geschat)

1 maart 2035

Studie voltooiing (Geschat)

1 maart 2037

Studieregistratiedata

Eerst ingediend

25 juni 2024

Eerst ingediend dat voldeed aan de QC-criteria

21 oktober 2024

Eerst geplaatst (Werkelijk)

22 oktober 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 september 2026

Laatste update ingediend die voldeed aan QC-criteria

27 september 2026

Laatst geverifieerd

1 september 2025

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SYSKY-2024-342-01

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren