To the Editor:
We read with great interest the article by Morgante et al. entitled, “The role of inositol supplementation in patients with polycystic ovary syndrome, with insulin resistance, undergoing the low-dose gonadotropin ovulation induction regimen,” which has been recently published in Fertility and Sterility.
We do have some concerns about methodology and conclusions of this study.
First of all, we do not understand the choice of a product whose indications are “pelvic inflammation and pain from oxidative stress”. Indeed, the multivitamin complex composition fully reflects the proposed indication: inositol, lattoferrin, magnesum, zinc, selenium, β-carotene, vitamin C, vitamin E, vitamin B6, bromelian, and glutathione.
A major concern is that, despite the complex product composition, the control group received no treatment. Therefore, the conclusion that inositol administration diminishes the chance of multifollicular development and its consequences is a clear overstatement.
Furthermore, I have some concerns about the reliability of pregnancy rates calculated on “timed intercourse” rather than by in vitro fertilization, without reporting information about sperm quality or other parameters that could influence conception.
Last, but not least, the treatment period is not standardized, since patients were treated at maximum for 4 weeks.
On this basis, to assure clarity of the information provided to the scientific community, a reply of the authors to these points is advised.
Ettore Cittadini, M.D.
Reproductive Biology Center
1. Morgante G, Orvieto R, Di Sabatino A, Musacchio MC, De Leo V. The role of inositol supplementation in patients with polycystic ovary syndrome, with insulin resistance, undergoing the low-dose gonadotropin ovulation induction regimen. Fertil Steril. 2011 Feb 5.
Published online in Fertility and Sterility doi:10.1016/j.fertnstert.2011.03.100
The Authors Respond:
We would like to thank Dr. Cittadini for his interest in our study (1). As was already mentioned, our preliminary study showed that Inositol nutritional supplementation reduces cancellation rate and improves pregnancy rate in insulin-resistant PCOS patients undergoing the low-dose gonadotropin step-down ovulation-induction regimen, as compared to a matched historical cohort.
Couples were treated at least 4 weeks prior to ovulation induction (typographical error), and those with male factor infertility were excluded. Moreover, by using the low-dose gonadotropin step-down ovulation-induction regimen, conducted by senior expert physicians, we achieved good results that are comparable to previously published data (2).
Regarding Redestop, this nutritional supplementation has a specific composition, containing in addition to inositol, also bromelin and lactoferrine, both known for their anti-inflammatory activity. PCOS women may exhibit an elevation in circulating CRP, a well-known indication of existing molecular evidence of chronic low-grade inflammation, which may underline the pathogenesis of this disorder (3). Therefore, the use of Redestop, with the combined anti-inflammatory and anti-diabetogenic (improves insulin sensitivity) properties is comprehensible, and was chosen as our nutritional product, tailored to our PCOS patients. We emphasize that Redestop is a nutraceutical product, not a drug, and it may be used for different indications, in which even a single component could have a role.
Giuseppe Morgante, M.D.
Department of Obstetrics and Gynecology
University of Siena
Policlinico Santa Maria Le Scotte
1. Morgante G, Orvieto R, Di Sabatino A, Musacchio MC, De Leo V. The role of inositol supplementation in patients with polycystic ovary syndrome, with insulin resistance, undergoing the low-dose gonadotropin ovulation induction regimen. Fertil Steril. 2011 Feb
2. Christin-Maitre S, Hugues JN. A comparative randomized multicentric study comparing the step-up versus step-down protocol in polycystic ovary syndrome. Hum Reprod 2003;18:1626–1631.
3. Escobar-Morreale HF, Luque-Ramírez M, González F. Circulating inflammatory markers in polycystic ovary syndrome: a systematic review and metaanalysis. Fertil Steril. 2011;95(3):1048-58.
Published online in Fertility and Sterility doi:10.1016/j.fertnstert.2011.03.101