04.14.22
A proprietary maternal supplement marketed by Gnosis by Lesaffre as Quatrefolic was evidenced in a recent human clinical trial to improve pregnancy and live birth outcomes in infertile women compared to supplementation with a standard folate ingredient.
The findings, appearing in International Journal of Environmental Research and Public Health, analyzed the pregnancy outcomes of 269 infertile women who were undergoing assisted reproductive technologies (ART), a group of widely used procedures for the control and treatment of infertility. According to Gnosis by Lesaffre, pre-conceptional, including nutritional status, may play a role in this initial phase.
So, the authors compared folic acid, which is considered the standard supplement for preconception care, with the formulation of 5-Methyltetrahydrofolate (5-MTHF) and vitamin B12 in the group of women. According to the authors, the homocysteine pathway in the preconception period should be evaluated to highlight micronutrient deficiencies, and warrants optimal multivitamin supplementation.
Results
In the group of women who took Quatrefolic, the authors noted that the mean number of Metaphase II oocytes (eggs before fertilization) and the pronuclear stage fertilization rate scores were higher than in those who supplemented with folic acid.
A higher percentage of women had a clinical pregnancy and life birth in comparison to the folic acid group
By the end of the study period, 60.4% of women in the Quatrefolic group achieved clinical pregnancy, compared to 44.9% in the folic acid group. Live birth rates were 48.6% for the Quatrefolic group and 35.4% for the folic acid group. Lastly, there was a statistically significant difference of miscarriage between the two groups (11.7% vs. 8.9%).
This led the authors to conclude that “women undergoing homologous ART supplemented with 5-MTHF and vitamin B12, have a higher chance of clinical pregnancy and live birth in comparison to those supplemented with folic acid. Further prospective studies and randomized clinical trials are needed to elucidate the effects of folate, vitamin B12, and homocysteine pathway in improving pregnancy outcomes in women after ART. If our findings were confirmed, this relatively inexpensive supplementation with vitamin B complex might be considered in clinical practice, particularly in women undergoing ART.”
“We are excited to see the increasing volume of publications related to the role of the biologically active form 5-MTHF as a better option than folic acid in fertility problems and pregnancy outcomes,” Silvia Pisoni, global market manager of reproduction and women’s health with Gnosis by Lesaffre, said. She noted that the study complements other clinical trials, which provided evidence that Quatrefolic could benefit couples with a history of fertility problems such as recurrent fetal loss, premature ovarian insufficiency, or abnormal sperm parameters.1-4
“Quatrefolic is proven to be a real solution with beneficial innovated features that match totally to the requirements of physicians and doctors to provide effective solutions and increase consumers’ compliance,” Pisoni said.
References
1. Servy EJ et al. (2018) MTHFR isoform carriers. 5MTHF vs. folic acid: a key to pregnancy outcomes. 35:1431–5.
2. Servy EJ, Ménézo et al. (2017) The hazards of excessive folic intake in MTHFR gene mutation carriers: an obstetric and gynecological perspective. Clin Obstet Gynecol Reprod Med 2017; 3.
3. Clément A et al. et. al (2020) 5-Methyltetrahydrofolate reduces blood homocysteine level significantly in C677T methyltetrahydrofolate reductase single-nucleotide polymorphism carriers consulting for infertility, J Gynecol Obstet Hum Reprod 49:101622.
4. Ménézo Y et al. (2021) MTHFR SNPs and homocysteine in patients referred for investigation of fertility. J Assist Reprod Genet 2021
The findings, appearing in International Journal of Environmental Research and Public Health, analyzed the pregnancy outcomes of 269 infertile women who were undergoing assisted reproductive technologies (ART), a group of widely used procedures for the control and treatment of infertility. According to Gnosis by Lesaffre, pre-conceptional, including nutritional status, may play a role in this initial phase.
So, the authors compared folic acid, which is considered the standard supplement for preconception care, with the formulation of 5-Methyltetrahydrofolate (5-MTHF) and vitamin B12 in the group of women. According to the authors, the homocysteine pathway in the preconception period should be evaluated to highlight micronutrient deficiencies, and warrants optimal multivitamin supplementation.
Results
In the group of women who took Quatrefolic, the authors noted that the mean number of Metaphase II oocytes (eggs before fertilization) and the pronuclear stage fertilization rate scores were higher than in those who supplemented with folic acid.
A higher percentage of women had a clinical pregnancy and life birth in comparison to the folic acid group
By the end of the study period, 60.4% of women in the Quatrefolic group achieved clinical pregnancy, compared to 44.9% in the folic acid group. Live birth rates were 48.6% for the Quatrefolic group and 35.4% for the folic acid group. Lastly, there was a statistically significant difference of miscarriage between the two groups (11.7% vs. 8.9%).
This led the authors to conclude that “women undergoing homologous ART supplemented with 5-MTHF and vitamin B12, have a higher chance of clinical pregnancy and live birth in comparison to those supplemented with folic acid. Further prospective studies and randomized clinical trials are needed to elucidate the effects of folate, vitamin B12, and homocysteine pathway in improving pregnancy outcomes in women after ART. If our findings were confirmed, this relatively inexpensive supplementation with vitamin B complex might be considered in clinical practice, particularly in women undergoing ART.”
“We are excited to see the increasing volume of publications related to the role of the biologically active form 5-MTHF as a better option than folic acid in fertility problems and pregnancy outcomes,” Silvia Pisoni, global market manager of reproduction and women’s health with Gnosis by Lesaffre, said. She noted that the study complements other clinical trials, which provided evidence that Quatrefolic could benefit couples with a history of fertility problems such as recurrent fetal loss, premature ovarian insufficiency, or abnormal sperm parameters.1-4
“Quatrefolic is proven to be a real solution with beneficial innovated features that match totally to the requirements of physicians and doctors to provide effective solutions and increase consumers’ compliance,” Pisoni said.
References
1. Servy EJ et al. (2018) MTHFR isoform carriers. 5MTHF vs. folic acid: a key to pregnancy outcomes. 35:1431–5.
2. Servy EJ, Ménézo et al. (2017) The hazards of excessive folic intake in MTHFR gene mutation carriers: an obstetric and gynecological perspective. Clin Obstet Gynecol Reprod Med 2017; 3.
3. Clément A et al. et. al (2020) 5-Methyltetrahydrofolate reduces blood homocysteine level significantly in C677T methyltetrahydrofolate reductase single-nucleotide polymorphism carriers consulting for infertility, J Gynecol Obstet Hum Reprod 49:101622.
4. Ménézo Y et al. (2021) MTHFR SNPs and homocysteine in patients referred for investigation of fertility. J Assist Reprod Genet 2021