P-505 Role of intramuscular immunoglobulin in improving the live birth rate in ANA positive women with recurrent pregnancy loss
Authors: Sadasivam S R , Arumugam I , Sadasivam K 
Published: June 2023

Study question

In ANA positive women with Recurrent Pregnancy Loss, could addition of intramuscular Immunoglobulin along with appropriate adjuvant therapy improve the live birth rate ?

Summary answer

In ANA positive RPL patients, addition of Intramuscular immunoglobulin along with glucocorticoids and low dose aspirin improves the live birth rate

What is known already

RPL is a frustrating condition which affects 1-3% of women trying to conceive. Presence of ANA is associated with autoimmunity, which affects trophoblast development and vascular remodeling process thereby resulting in pregnancy loss. Latest ESHRE guidelines also suggest ANA testing for explanatory purpose. Aspirin has anti-platelet and anti-inflammatory effects, and glucocorticoids exhibit a beneficial effect in autoimmune diseases. Therefore, they are considered conventional adjuvant therapies in ANA-positive women with RPL. Addition of Immunoglobulin for RPL patients benefits by the down-regulation of primary antibody production, the modulation of complement activation and Suppresses Nk cell cytotoxicity

Study design, size, duration

72 ANA positive patients with Unexplained RPL were enrolled in the study. Anatomical, metabolic ,genetic and other immunological causes for RPL were excluded. Out of 72 patients 36 patients were allotted to the treatment group, who received intramuscular immunoglobulins along with Low dose aspirin and glucocorticoids, remaining 36 patients were allotted to the control group, who received only Aspirin and glucocorticoids. Duration of study extended from jan2021 till Dec 2022

Participants/materials, setting, methods

72 patients with unexplained RPL underwent ANA screening using Indirect Immunofluorescence technique in the pre conception period. Patients with a titre ≥1:80 were considered to be significant and enrolled in the study. Patients were allotted to the Treatment and Control group based on personal choice of the patient after informed consent. Live birth rate was the primary outcome analyzed.

Main results and the role of chance

There were no significant differences in socio-demographic characteristics between group. Patient characteristics – Age, BMI, Ovarian reserve, sperm factor and number of previous Pregnancy losses were matched.Treatment group who received Intramuscular immunoglobulin once in 3 weeks right from the time of positive pregnancy test till 28 weeks along with low dose aspirin and glucocorticoids had a live birth rate of (23/36 ) 63.8 % whereas Control group who received only Low dose Aspirin (75 mg) and Glucocorticoids had a live birth rate of 41.6 % (15/36). Other obstetric outcomes which were analysed were Pre Eclampsia and GDM which were comparable between both the groups.Preterm labour was marginally higher in the control group.

Limitations, reasons for caution

Because of limited sample size results need to be interpreted with caution. Screening for ANA antibodies in patients were done only preconceptionally, and we were not aware about their ANA titres in pregnancy. This study involves only patients who conceived with IVF treatment and doesn't include spontaneous natural conception

Wider implications of the findings

ANA screening in RPL cases is suggested to prognosticate the outcome. Addition of Immunoglobulins significantly increases the live birth rate in these cases. Role of Immunoglobulin in patients with altered cellular immunity has to be further studied which is likely to benefit other cases of unexplained RPL.

Trial registration number

not applicable