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Wpływ HCQ w połączeniu z LT4 na LBR u kobiet w stanie eutyreozy z URPL i TPO-Ab (QT-LIFE)

27 września 2026 zaktualizowane przez: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Skuteczność hydroksychlorochiny w połączeniu z lewotyroksyną u kobiet w stanie eutyreozy z dodatnim wynikiem badania na obecność przeciwciał przeciwtarczycowych i niewyjaśnioną nawracającą utratą ciąży: wieloośrodkowe, randomizowane badanie kontrolowane

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

796

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Chiny
    • Guangdong
      • Guangzhou, Guangdong, Chiny, 510120
      • Guangzhou, Guangdong, Chiny, 510000
        • Rekrutacyjny
        • Sun Yat-Sen Memorial Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

20 lat do 40 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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%.
Lek: 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.
Inny: 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%.
Lek: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Birth of a living child beyond 28 weeks
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Clinical pregnancy at 5 to 8 weeks
Ramy czasowe: 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
Ramy czasowe: At 28 weeks of pregnancy

Miscarriage that occurs less than 28 weeks of gestation
At 28 weeks of pregnancy
Gestation at miscarriage, weeks
Ramy czasowe: 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
Ramy czasowe: At 12 weeks of pregnancy

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

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

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 listopada 2024

Zakończenie podstawowe (Szacowany)

1 marca 2035

Ukończenie studiów (Szacowany)

1 marca 2037

Daty rejestracji na studia

Pierwszy przesłany

25 czerwca 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 października 2024

Pierwszy wysłany (Rzeczywisty)

22 października 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

30 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 września 2026

Ostatnia weryfikacja

1 września 2025

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • SYSKY-2024-342-01

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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