Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

  • End date
    Jan 24, 2023
  • participants needed
  • sponsor
    Rigshospitalet, Denmark
Updated on 1 March 2022
discoid lupus erythematosus


Recurrent pregnancy loss (RPL) defined as 3 or more pregnancy losses affects approximately 3% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth. Exciting indications for using Hydroxychloroquine (HCQ) include: Malaria profylaxis and treatment, systemic and discoid lupus erythematosus (SLE) and rheumatoid athritis (RA). HCQ has been reported to have the following properties (anti-thrombotic, vascular-protective, immunomodulatory, improving glucose tolerance, lipid-lowering, and anti-infectious).

There is no data concerning the benefit of HCQ in RPL. Administration for other indications provides extensive safety data during pregnancy.

This study has the potential to establish support for a new treatment option for unexplained RPL.

Condition Recurrent Pregnancy Loss
Treatment hydroxychloroquine, Hydroxychloroquine Placebo
Clinical Study IdentifierNCT03305263
SponsorRigshospitalet, Denmark
Last Modified on1 March 2022


Yes No Not Sure

Inclusion Criteria

4 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL
3 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL with minimum one second trimester loss

Exclusion Criteria

Age below 18 years or above 39 at inclusion
Abnomal uterine anatomi at hysterosalpingography/hysteroscopy or hydrosonography
Chromosomal abnormalities within the couple
Menstrual cycle below 23 days or above 35 days
Lupusantikoagulans positivity or immunoglobulin (Ig)G/IgM anticardiolipinantibodies (10 GPL kU/l at Rigshospitalets Laboratorium) or plasma homocystein 25 mikrogr./l at repeated measurement with 12 weeks interval
HIV or Hepatitis B or C positive
Psoriasis, retinopathy og serious imparied hearing (Contraindications for HCQ)
Chronic disease that lead to intake of immunemodulatory drugs or potentially pregnancy toxic agents
Hemoglobin 6.5 mmol/L, leukocytes <3.5 E9/L, platelets <145 E9/L at inclusion
Previous treatment with HCQ in pregnancy
>1previous live birth
previous participation in this trial
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