Edu Antoine1, Sergiu Chirila2, Cristina Teodorescu1. 1. Obstetrics and Gynaecology Department, "Nicolae Malaxa" Clinical Hospital, Bucharest, Romania. 2. Faculty of Medicine, "Ovidius" University of Constanta, Romania.
Abstract
Background:Statistics from recent years have shown that 40% of infertile couples have a female etiological factor, 40% a male etiology and the remaining 20% a combination of female and male factors. For fertile couples, the chance of getting pregnant is 57% in three months of attempts, 75% in six months, 90% in one year, and 95% in two years. One-third of infertile couples have more than one cause involved in their inability to conceive. In 10-20% of cases, the reason for infertility cannot be determined. Approximately 25% of infertile women have ovulatory dysfunction. Objectives: This research investigates improvements on the fertility of couples following treatment with a daily tablet of the patented blend consisting in a combination of Vitex agnus-castus (Vitex) extract, Lepidium meyenii (Maca) extract and active folate alone or with a gel capsule of vitamin, minerals, oligo-elements plus DHA and EPA Omega 3 fatty acids. Materials and methods:Multicenter prospective interventional study with a duration of 18 months, conducted between June 2016 and December 2017. A total of 189 women were enrolled in the study. Participants were assigned to two treatment groups: group A, consisting of 103 patients who received adaily tablet of the patented blend consisting in a combination of Vitex extract, Maca extract and active folate, and group B, consisting of 86 patients who were given a daily tablet of the patented blend also administered to Group A and a gel capsule of vitamins, minerals, oligo-elements plus DHA and EPA omega 3 fatty acids. Paraclinical tests were conducted upon inclusion in the study and six months after treatment initiation in case of non-pregnancy. Every patient received ovulation kits and ovulation tests were performed on day 14 of the menstrual cycle. Outcomes:Average age of the women was 31.18 years (SD 5.18 years). There was a successful pregnancy rate of 37%, with no difference between the two arms of the study. The number of new pregnancies was relatively constant through the study duration. The number of women with ovulation increased from 10% to 42.9% by the end of the study. During the six-month-period of the study, there were no side effects reported between patients of the two groups. Conclusions:The supplement may be used by women trying to conceive. The patented blend consisting of a combination of Vitex, Maca and active folate regulates the menstrual cycle, stimulates ovulation and increases the likelihood of getting pregnant.
RCT Entities:
Background:Statistics from recent years have shown that 40% of infertile couples have a female etiological factor, 40% a male etiology and the remaining 20% a combination of female and male factors. For fertile couples, the chance of getting pregnant is 57% in three months of attempts, 75% in six months, 90% in one year, and 95% in two years. One-third of infertile couples have more than one cause involved in their inability to conceive. In 10-20% of cases, the reason for infertility cannot be determined. Approximately 25% of infertilewomen have ovulatory dysfunction. Objectives: This research investigates improvements on the fertility of couples following treatment with a daily tablet of the patented blend consisting in a combination of Vitex agnus-castus (Vitex) extract, Lepidium meyenii (Maca) extract and active folate alone or with a gel capsule of vitamin, minerals, oligo-elements plus DHA and EPA Omega 3 fatty acids. Materials and methods:Multicenter prospective interventional study with a duration of 18 months, conducted between June 2016 and December 2017. A total of 189 women were enrolled in the study. Participants were assigned to two treatment groups: group A, consisting of 103 patients who received a daily tablet of the patented blend consisting in a combination of Vitex extract, Maca extract and active folate, and group B, consisting of 86 patients who were given a daily tablet of the patented blend also administered to Group A and a gel capsule of vitamins, minerals, oligo-elements plus DHA and EPA omega 3 fatty acids. Paraclinical tests were conducted upon inclusion in the study and six months after treatment initiation in case of non-pregnancy. Every patient received ovulation kits and ovulation tests were performed on day 14 of the menstrual cycle. Outcomes:Average age of the women was 31.18 years (SD 5.18 years). There was a successful pregnancy rate of 37%, with no difference between the two arms of the study. The number of new pregnancies was relatively constant through the study duration. The number of women with ovulation increased from 10% to 42.9% by the end of the study. During the six-month-period of the study, there were no side effects reported between patients of the two groups. Conclusions:The supplement may be used by women trying to conceive. The patented blend consisting of a combination of Vitex, Maca and active folate regulates the menstrual cycle, stimulates ovulation and increases the likelihood of getting pregnant.
Authors: Imran Patanwala; Maria J King; David A Barrett; John Rose; Ralph Jackson; Mark Hudson; Mark Philo; Jack R Dainty; Anthony J A Wright; Paul M Finglas; David E Jones Journal: Am J Clin Nutr Date: 2014-06-18 Impact factor: 7.045