Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-13 @ 1:53 PM
Study NCT ID:
NCT02379650
Status:
WITHDRAWN
Last Update Posted:
2016-08-12
First Post:
2015-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
RCT Assessing Hydroxychloroquine for Unexplained Recurrent Pregnancy Loss
Status:
WITHDRAWN
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Testing required by FDA for IND approval was too expensive to move forward with conduct of the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recurrent pregnancy loss (RPL) affects 5% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the likelihood of a pregnancy resulting in a live birth. This leads to significant patient and provider frustration and emotional stress. Hydroxychloroquine (HCQ) is a medication commonly used in pregnancy to treat autoimmune and connective tissue diseases such as systemic lupus erythematosus (SLE). This use has shown that HCQ is very safe in pregnancy. HCQ has anti-inflammatory and anti-thrombotic effects and thus may improve pregnancy outcomes in couples with unexplained RPL. Although some providers are already prescribing HCQ for unexplained RPL, a randomized controlled trial is necessary to determine the true efficacy and safety of this treatment. This study has the potential to establish support for a new treatment option for unexplained RPL.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: