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Intrauterine Administration of Activated Peripheral Blood Mononuclear Cells in Intrauterine Insemination: A Prospective Double-Blind Randomized Clinical Trial

Published:November 27, 2021DOI:https://doi.org/10.1016/j.jogc.2021.11.010

      Abstract

      Objective

      To evaluate the effect of intrauterine administration of activated peripheral blood mononuclear cells (PBMC) on intrauterine insemination (IUI) success rates.

      Methods

      This prospective double-blind randomized parallel clinical trial included 213 patients undergoing IUI at the Fertilys clinic. PBMC were isolated on the day of ovulation (day 0; D0) and stimulated with phytohemagglutinin (PHA) and human chorionic gonadotropin (hCG) for 48 hours (day 2; D2). Patients in the PBMC group (n = 108) underwent in utero administration of 1.106 cells on D2, while patients in the control group (n = 105) were administered sperm-washing medium. Distribution of CD4 T lymphocyte populations (n = 61) was assessed on D0 and D2. Pregnancy and live birth rates were also evaluated.

      Results

      Demographic and clinical characteristics, pregnancy rates, and live birth rates were not significantly different between the PBMC and control groups. Significantly higher levels of T helper (Th) 2, Th22, and T regulatory cells (P < 0.0001) and lower levels of Th17 cells were observed in hCG-activated PBMC at D2 than at D0.

      Conclusion

      Intrauterine administration of PBMC was not beneficial in IUI patients. New clinical approaches to better identify patients requiring endometrium immunomodulation needs to be addressed.

      Résumé

      Objectif

      Évaluer l’effet de l’administration intra-utérine de cellules mononucléées du sang périphérique (CMSP) sur le taux de réussite de l’insémination intra-utérine (IIU).

      Méthodologie

      Cet essai clinique randomisé prospectif à double insu avec volets parallèles a été mené auprès de 213 patientes devant subir une IIU à la clinique Fertilys. Les CMSP ont été isolées le jour de l’ovulation (jour 0; J0) et stimulées par phytohémagglutinine (PHA) et gonadotrophine chorionique (hCG) pendant 48 heures (jour 2; J2). Les patientes du groupe CMSP (n = 108) ont subi une administration in utero de 1,106 cellules au J2, tandis que les patientes du groupe témoin (n = 105) ont reçu seulement le liquide de lavage du sperme. La distribution des populations de lymphocytes T CD4 (n = 61) a été évaluée aux jours J0 et J2. Les taux de grossesses et de naissances vivantes ont aussi été évalués.

      Résultats

      Les caractéristiques démographiques et cliniques, le taux de grossesses et le taux de naissances vivantes n’étaient pas significativement différents entre le groupe CMSP et le groupe témoin. Une augmentation du taux de lymphocytes T auxiliaires de type 2 (TH2), de lymphocytes Th22 et de lymphocytes T régulateurs (p < 0,0001) et une diminution du taux de lymphocytes Th17 ont été observées dans les CMSP activées par hCG au J2 par rapport au J0.

      Conclusion

      L’administration intra-utérine de CMSP ne s’est pas avérée bénéfique chez les patientes recevant une IIU. Il faut continuer les recherches pour trouver de nouvelles stratégies cliniques afin de mieux identifier les patientes nécessitant une immuno-modulation de l’endomètre.

      Keywords

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