Intravenous Immunoglobulin and Prednisolone for RPL After ART.
Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
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 chance of live birth exists. In unexplained cases of RPL, primarily the
immune system is hypothesized to play a pivotal, causative role, since autoantibodies and
specific human leukocyte antigen (HLA) alleles as well as unbalanced distribution of
leucocyte subsets, especially natural killer (NK) cells and T-helper (Th) cells, occurs more
frequently in patients with unexplained RPL. For that reason, many treatment regimens used in
autoimmune diseases have been tested on RPL patients, as for example prednisolone and
intravenous immunoglobulin (IVIg).
IVIg (Privigen) consist of a broad spectrum of structurally and functionally intact IgG
antibodies. The mechanism of action is not fully elucidated, but certainly IVIg do help
opsonise and neutralize foreign cells and pathogens. Prednisolone support this
anti-inflammatory action by suppressing migration of polymorphonuclear leukocytes, and
reducing volume of the immune system, capillary permeability, and immune cell activity.
A retrospective, observational pilot study suggested that a combination of prednisone and
IVIg in first trimester improves the chance of a live birth in women with RPL after assisted
reproductive technologies (ART) (Nyborg et al., 2014).
A randomized controlled study is necessary for determining if this immunomodulatory treatment
is definitely effective in patients with unexplained RPL after ART (defined as IVF or ICSI
treatment). Potentially, this study will be able to establish a new treatment to women with
unexplained RPL after ART, who otherwise have a poor prognosis.
Phase:
Phase 2
Details
Lead Sponsor:
Caroline Nørgaard-Pedersen
Collaborators:
Beckett Foundation Clinical Immunological Department, Aalborg University Hospital GCP department of Aalborg University Hospital L.F. Foghts Foundation Svend Andersen Fonden The Pharmacy of Aalborg University Hospital