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

Phase 1

Active, not recruiting

• Conditions: Recurrent pregnancy loss after assisted reproductive technology treatment; MedDRA version: 20.0Level: LLTClassification code 10078356Term: Recurrent pregnancy lossSystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2020-000256-35-DK
• Lead Sponsor: Aalborg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-14
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

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

Exclusion Criteria

BMI =35
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified