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Hydroxychloroquine treatment for Recurrent Pregnancy Loss: a randomized double-blind placebo-controlled trial
EU CTIS ID: 2024-515579-36-00
What this study is testing
To monitor the difference in live birth rate (LBR) among women allocated to treatment with Hydroxychloroquine (HCQ) and those allocated to placebo treatment, without exclusion of any included patients (Intention to treat (ITT) analysis).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥ 4 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained recurrent pregnancy loss (RPL)
- ≥ 3 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL with minimum one second trimester loss
You likely can't join if
- Age < 18 years or > 40 years
- Previous HCQ treatment in relation to conceive
- > 1 previous live birth.
- Previous participation in current study.
- Prominent uterine abnormalities detected by hysterosalpingography/hysteroscopy or hydrosonography
- Known prominent chromosome abnormalities for the couple trying to conceive
See the full eligibility criteria
- ≥ 4 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained recurrent pregnancy loss (RPL)
- ≥ 3 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL with minimum one second trimester loss
- Age < 18 years or > 40 years
- Previous HCQ treatment in relation to conceive
- > 1 previous live birth.
- Previous participation in current study.
- Prominent uterine abnormalities detected by hysterosalpingography/hysteroscopy or hydrosonography
- Known prominent chromosome abnormalities for the couple trying to conceive
- A menstrual cycle < 23 days or > 35 days if the pregnancy is conceived naturally. If the woman received fertility treatment the menstrual cycle has no consequence.
- Detection of positive lupus-anticoagulant or positive IgG/IgM for anticardiolipin-antibodies (≥10 GPL kU/l, measured at the same laboratories at the Capital Region of Denmark) or plasma homocysteine ≥25 microgram/l by repeated measurements 12 weeks apart before the pregnancy.
- Positive HIV test or test indicating chronic hepatitis B or C.
- Psoriasis, retinopathic or serious hearing deficiency (contraindication for treatment with HCQ)
- Current chronic disease implicating a constant consumption of immunomodulatory medicine or medicine potentially harmful to the pregnancy/embryo
- Hgb ≤ 6.5 mmol/L, leucocytes < 3.5 E9/L, thrombocytes < 145 E9/L by the time of inclusion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.