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Minerva Ginecol. 2018 Apr;70(2):129-137. doi: 10.23736/S0026-4784.17.04144-2. Epub 2017 Oct 9.

Can unexplained infertility be evaluated by a new immunological four-biomarkers panel? A pilot study.

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San Carlo Clinic, Paderno Dugnano, Milan, Italy.
Department of Women's and Children's Health, Agostino Gemelli Foundation University Hospital, Rome, Italy.
Innovitas Vitae srl, Gerenzano, Varese, Italy.
Innovitas Vitae srl, Gerenzano, Varese, Italy -



Inflammation and oxidative stress are known to be triggering factors for a decrease of the pregnancy rate like maternal immunosuppression. Under these circumstances our study was performed to verify four immunological biomarkers (IMMUNOX Panel) in terms of incidence in a sine-causa infertile population and the overall pregnancy rate when the Panel was showing some non-physiologic values.


Sera of 86 women affected by unexplained infertility were screened for the IMMUNOX panel of biomarkers composed by: tumor necrosis factor alpha (TNF-α,) glycodelin (GLY), total oxidative status (TOS), and complement activity toxic factor (CATF). When at least one of the biomarkers tested was showing values outside the physiologic range, the woman was considered IMMUNOX-Positive.


The first data was indented to verify the incidence of the women with an IMMUNOX-positive panel. Results show that 19.8%, 18.6%, 25.6%, and 47.7% were IMMUNOX-positive for GLY, TNF-α, TOS and CATF respectively. The overall incidence of IMMUNOX-positive patients, with at least one biomarker positive was 70,9%. Subsequently we have analysed the correlation between IMMUNOX Panel positivity and the pregnancy rate. The pregnancy rate in a subgroup (N.=55) of the entire population tested (N.=86) was 2.9% and 36.6% for the IMMUNOX-positive and IMMUNOX-negative patients respectively.


Further validation studies are needed to prove that there is a correlation between unexplained infertility and immunological disorders screened by the IMMUNOX Panel, nevertheless our data shows that this diagnostic approach may be helpful to predict and to identify women at higher risk of IVF cycles failure.

[Indexed for MEDLINE]

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