A Pilot Prospective Study Evaluating the Effect of Curcuma-Based Herbal Food Supplement on the Outcome of In Vitro Fertilization in Patients Testing Positive for Four Immunological Biomarkers.

Background and Objectives: Inflammation and oxidative stress have been described to reduce the chance for pregnancy instauration and maintenance. NOFLAMOX, a recently developed herbal preparation with recognized antioxidant and anti-inflammatory properties, can represent an interesting treatment to increase the chance of pregnancy, both physiological or after in vitro fertilization (IVF). The aim of this study was to assess NOFLAMOX's effect; a population with unexplained infertility was screened for the recently described IMMUNOX panel based on four immunological biomarkers with a prospective study approach. Materials and Methods: Patients with unexplained infertility and positive for at least one of the biomarkers of the IMMUNOX panel were included in this study and treated with NOFLAMOX for three months prior to an IVF cycle. Results: Eighty-six patients (n = 86) were screened with the IMMUNOX panel and the forty-seven (54.5%) found positive were included in this study. In more detail, 11 were positive for TNFα (23.4%), 18 (38.3%) for glycodelin (GLY), 29 (61.7%) for Total Oxidative Status (TOS), and 32 (68.1%) for Complement Activity Toxic Factor (CATF). After three months of treatment, a significant reduction in the number of IMMUNOX-positive patients was observable, with 26 patients who turned IMMUNOX-negative displaying a quantitative statistically significant variation of 100% (11/11), 38.9% (7/18), 65.5% (18/29), and 75% (24/32), for TNFα, glycodelin, TOS, and CATF, respectively. Followed in the subsequent IVF cycle, this NOFLAMOX-treated population showed a pregnancy rate of 42.3% compared to the 4.7% of the IMMUNOX-positive group of patients. Conclusions: Taken together, the results of this study suggest that NOFLAMOX could represent an interesting option for those patients with unexplained infertility of inflammatory/oxidative origin. Further studies are needed to confirm these results and explore possible strategies to restore fertility in women with immune-mediated sterility.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.