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Exeltis USA, Inc. Releases Results of Novel Prospective Web-Based Consumer Study: Women with Self-Described PCOS Taking Pregnitude®, a Doctor-Recommended Fertility Supplement: Approximately 60 Percent of Study Participants Achieved Pregnancy

05:18 EDT 4 Aug 2017 | PR Newswire

FLORHAM PARK, N.J., Aug. 4, 2017 /PRNewswire/ -- Exeltis USA, Inc., an integrated health science company, has announced results of its Pregnitude® Reproductive App Marketing (PRAM) study in collaboration with a popular fertility app for women who self-describe as suffering from polycystic ovary syndrome (PCOS), a hormonal imbalance that can cause irregular menstrual cycles-making it difficult to conceive. "Of the 152 users who regularly monitored, track and record their menstrual cycles on this fertility app, approximately 60 percent of the women taking Pregnitude® conceived during the 6-month trial -compared to 45 percent of the control group not taking the supplement," said Michael Krychman, MD, a board-certified obstetrician gynecologist in Newport, CA and the principal investigator of the PRAM Study. "Moreover, thirty percent of the Pregnitude® pregnancies occurred within the first 3 months."

This novel app research allowed participants to use their smart phone to input detailed information anonymously. The PRAM study was compliant to the Health Insurance Portability and Accountability Act (HIPPA) protocols to ensure complete protection of all research data.

Pregnitude® is a doctor-recommended fertility support dietary supplement for women especially formulated for reproductive health and improved egg quality. Pregnitude® is the only fertility supplement to provide the twice daily therapeutic dosages of nutrients outlined in clinical support documentation. (1) (2) "The PRAM study showed that Pregnitude®, a natural fertility supplement, had noticeable efficacy for women who were having trouble conceiving," said Dr. Krychman, "Having a non-prescription fertility supplement available to them before they move on to more aggressive, often financially burdensome medical therapies and interventions, shows great promise for this population," adds Dr. Krychman.

About the PRAM StudyThe PRAM study was conducted among a select population—women with self-reported PCOS to test the efficacy of Pregnitude®. This approach to consumer research was the first time that digital technology was used in tandem with tracking the efficacy of a fertility-boosting dietary product among women who are actively trying to get pregnant. The hypothesis was that the Pregnitude® users (as opposed to the control group), who were also entering and tracking a range of fertility-related data, would have more regular menses and by extension more regular ovulation and improved egg formation, which could lead to pregnancy. In addition to PCOS, maternal age is a known factor among women struggling to conceive, as the quality of a woman's eggs begins to decline after age 30-35. The PRAM participants ranged from 20 to 38 years old with an average age of 29. The conception rate and time to conception are significant across the entire active user population. Study highlights include:

  • One hundred fifty-two women were recruited with an average age of 28 (range 20-28).
  • Approximately 60 percent of patients on the supplement conceived during the 6-month trial compared to 45 percent of the controls. 
  • Thirty percent of the Pregnitude® pregnancies occurred within the first 3 months. 
  • More women on Pregnitude® reported cycle consistent regularity than those in the control group.
  • Menstrual length was 1.5 percent shorter in those who took the supplement.
  • The average Body Mass Index was 30 (range 22-33).
  • There was a bi-modal distribution of pregnancies- an initial peak at 1 month and then another spike at 5 months of consistent use.

PCOS is a common cause of infertility in women and it may be responsible for up to 70 percent of infertility issues in women who have difficulty ovulating, as reported by the PCOS Foundation (3). "Given that both PCOS and maternal age create known challenges to conception, it is provocative and significant that among study participants in the 31 to 35 age range, 24 percent conceived while using Pregnitude®," said Dr. Krychman. "These results indicate that Pregnitude® has the potential to make a life-changing difference for some women who struggle trying to conceive, particularly those with PCOS or irregular menses," adds Dr. Krychman.

"We are very pleased with the results of the PRAM study because it reflects the effectiveness of Pregnitude®," said Eduardo Fernandez, VP of Operations specializing in dietary supplements. "At Exeltis, we are committed to empowering women to be more proactive in managing their health, including their reproductive health."

For more information about the PRAM study criteria, please contact Eduardo Fernandez, VP-Operations, Exeltis USA, Inc.

About Pregnitude®Pregnitude® is a non-prescription, doctor recommended fertility dietary supplement sold in thousands of leading retail pharmacies, including Walgreens and CVS and available through major online retailers. To learn more about Pregnitude®, please visit: www.pregnitude.com.

About Exeltis USA, Inc.Exeltis USA, Inc. is committed to improving women's health at all stages of life and offers an extensive portfolio of products to meet women's reproductive health needs and help improve wellbeing and quality of life. For more information, please visit: http://womenshealth.exeltisusa.com/.

References

  1. Randomized, double-blind placebo-controlled trial: Effects of Myo-inositol on Ovarian Function and Metabolic Factors in Women with PCOS; S Gerri et al: European Review for Medical and Pharmacological Sciences, 2007.
  2. Effects of Myo-inositol Supplementation on Oocytes Quality in PCOS Patients: A Double-blind Trial; L. Ciotta et al: European Review for Medical and Pharmacological Sciences, 2011  
  3. PCOS Foundation www.PCOSFoundation.org

Contact: Barbara Ross
Ross Communications Inc.
bross@rosspr.com
201-236-1771

View original content:http://www.prnewswire.com/news-releases/exeltis-usa-inc-releases-results-of-novel-prospective-web-based-consumer-study-women-with-self-described-pcos-taking-pregnitude-a-doctor-recommended-fertility-supplement-approximately-60-percent-of-study-participants-achieve-300499767.html

SOURCE Exeltis USA, Inc.

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