Status:
COMPLETED
Intravenous Immunoglobulin and Prednisolone for RPL After ART.
Lead Sponsor:
Aalborg University Hospital
Collaborating Sponsors:
Svend Andersen Fonden
Beckett Foundation
Conditions:
Habitual Abortion
Recurrent Pregnancy Loss
Eligibility:
FEMALE
18-41 years
Phase:
PHASE2
Brief Summary
Recurrent pregnancy loss (RPL) affects around 5 % of women in reproductive age. The underlying cause of RPL is most often unknown, probably multifactorial, and no treatment with documented effect on c...
Detailed Description
In a randomized, double-blinded, placebo-controlled trial, this study aims to investigate whether treatment with prednisolone and intravenous immunoglobulin (IVIg) before and in early pregnancy improv...
Eligibility Criteria
Inclusion
- Women with ≥ 2 consecutive pregnancy losses (miscarriages or biochemical pregnancies) ≤ completed gestational week 10 after ART with the present partner or with an egg/semen donor\*
- The gestational week of the non-induced pregnancy losses will be based on the date of clinical signs of miscarriage or the fetus' crown-rump-length of a missed abortion measured on the ultrasonic scan detecting the pregnancy loss. If the participant plan to use egg donation in the study cycle, the previous two pregnancy losses must also have happened with the use of egg donation; however, it is not required to use the same egg donor in all three embryo transfers.
Exclusion
- BMI ≥35
- Age ≥41
- 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
- Treatment with medication interacting with prednisolone
- CYP3A4-inhibitors (fx erythromycin, itraconazole, ritonavir, lopinavir), CYP3A4-inductors (fx phenobarbital, phenytoin og rifampicin), loop diuretics, thiazides, amphotericin B, beta2-agonists, antidiabetics, interleukin-2, somatotropins, 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
- Previous treatment with IVIg
- Allergy to prednisolone and/or IVIg
- AMH \<4 pmol/L. If transfer of donor egg is planned for her IVF cycle, the AMH value will not be an exclusion criterion.
Key Trial Info
Start Date :
January 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04701034
Start Date
January 28 2021
End Date
April 18 2024
Last Update
November 24 2025
Active Locations (1)
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1
• The Centre for Recurrent Pregnancy Loss of Western Denmark, Department of Obstetrics and Gynaecology, Aalborg University Hospital
Aalborg, Denmark, 9000