Could immune drugs help prevent miscarriages after IVF? new trial results awaited.
NCT ID NCT04701034
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a combination of intravenous immunoglobulin (IVIg) and prednisolone can increase the chance of a live birth in women who have had two or more unexplained miscarriages after fertility treatments like IVF. Eighty women were randomly assigned to receive either the active drugs or a placebo during early pregnancy. The goal was to see if calming the immune system could help more pregnancies survive past the first trimester.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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80 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Apr 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 41 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: 1. BMI ≥35 2. Age ≥41 3. Significant uterine malformation(s) 4. Known parental balanced chromosomal translocations 5. ≥2 previous pregnancies with fetuses with known abnormal karyotype 6. Patients with IgA deficiency, IgA-autoantibodies or hyperprolinaemia 7. 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. 8. 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. 9. Patients with a clinical or biochemical profile indicating need for heparin or levothyroxine treatment during pregnancy 10. Previous treatment with IVIg 11. Allergy to prednisolone and/or IVIg 12. AMH \<4 pmol/L. If transfer of donor egg is planned for her IVF cycle, the AMH value will not be an exclusion criterion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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• The Centre for Recurrent Pregnancy Loss of Western Denmark, Department of Obstetrics and Gynaecology, Aalborg University Hospital
Aalborg, 9000, Denmark
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Other studies related to the condition(s) this trial covers.
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