Viewing Study NCT06652113



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Last Modification Date: 2024-10-26 @ 3:43 PM
Study NCT ID: NCT06652113
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-06-25

Brief Title: Effect of HCQ Combined With LT4 on LBR in Euthyroid Women With URPL and TPO-Ab
Sponsor: None
Organization: None

Study Overview

Official Title: The Efficacy of Hydroxychloroquine Combined With Levothyroxine in Euthyroid Women With Thyroid Antibody Positive and Unexplained Recurrent Pregnancy LossA Multicenter Randomized Controlled Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: QT-LIFE
Brief Summary: 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
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None