Intravenous immunoglobulin and prednisolone to women with unexplained recurrent pregnancy loss after assisted reproductive technology treatment: a randomised, double-blind, placebo-controlled trial

Aalborg University Hospital0 个研究点目标入组 74 人开始时间: 2020年9月14日最近更新: 2024年5月21日

适应症

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•Women with = 2 consecutive pregnancy losses (miscarriages or biochemical pregnancies) = gestational week 10 after ART with the present partner
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 74
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Age =41 years
•Significant uterine malformation(s)
•Known parental balanced chromosomal translocations
•=2 previous pregnancies with fetuses with known abnormal karyotype
•Patients with IgA deficiency, IgA-autoantibodies or hyperprolinaemia
•Anti-Müllerian hormone (AMH) <4 pmol/l if the planned IVF/ICSI cycle does not imply the use of donor egg. If IVF/ICSI with egg donation is planned, a low AMH value is not an exclusion criterion.
•Treatment with medication interacting with prednisolone:
•CYP3A4-inhibitors (fx erythromycin, itraconazol, ritonavir, lopinavir), CYP3A4-inductors (fx phenobarbital, phenytoin og rifampicin), loop diuretics, thiazides, amphotericin B, beta2-agonists, antidiabetics (metformin is acceptable), interleukin-2, somatropins, anticholinergics and regular treatment with NSAIDs.
•Patients with moderate/severe hypertension, diabetes mellitus, heart insufficiency, severe mental disorders, Cushing syndrome, myasthenia gravis, ocular herpes simplex, pheochromocytoma, systemic sclerosis, and moderate/severe renal dysfunction.
•Patients with a clinical or biochemical profile indicating need for heparin or levothyroxine treatment during pregnancy (see the description below)
•Previous treatment with IVIg
•Allergy to prednisolone and/or IVIg

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