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Management of women with PCOS using myo-inositol and folic acid. New clinical data and review of the literature.

Abstract

Introduction The use of 2 × 2000 mg myo-inositol +2 × 200 μg folic acid per day is a safe and promising tool in the effective improvement of symptoms and infertility for patients with polycystic ovary syndrome (PCOS). In addition, PCOS is one of the pathological factors involved in the failure of in vitro fertilization (IVF). Typically, PCOS patients suffer of poor quality oocytes. Patients and methods In an open, prospective, non-blinded, non-comparative observational study, 3602 infertile women used myo-inositol and folic acid between 2 and 3 months in a dosage of 2 × 2000 mg myo-inositol +2 × 200 μg folic acid per day. In a subgroup of 32 patients, hormonal values for testosterone, free testosterone and progesterone were analyzed before and after 12 weeks of treatment. The mean time of use was 10.2 weeks. In the second part of this trial it was investigated if the combination of myo-inositol + folic acid was able to improve the oocyte quality, the ratio between follicles and retrieved oocytes, the fertilization rate and the embryo quality in PCOS patients undergoing IVF treatments. Twenty-nine patients with PCOS, underwent IVF protocols for infertility treatment and were randomized prospectively into two groups. Group A (placebo) with 15 patients and group B (4000 mg myo-inositol +400 μg folic acid per day) with 14 patients were evaluated. The patients of group B used 2 months' myo-inositol + folic acid before starting the IVF protocol. For statistically analyses Student's t-test was performed. Results Seventy percent of the women had a restored ovulation, and 545 pregnancies were observed. This means a pregnancy rate of 15.1% of all the myo-inositol and folic acid users. In 19 cases a concomitant medication with clomiphene or dexamethasone was used. One twin pregnancy was documented. Testosterone levels changed from 96.6 ng/mL to 43.3 ng/mL and progesterone from 2.1 ng/mL to 12.3 ng/mL in the mean after 12 weeks of treatment (p < 0.05) Student's t-test. No relevant side effects were present among the patients. The women in the IVF treatment the group A showed a higher number of retrieved oocytes than group B. Nevertheless, the ratio follicle/retrieved oocyte was clearly better in the myo-inositol group (= group B). Out of the 233 oocytes collected in the myo-inositol group, 136 where fertilized whereas only 128 out of 300 oocytes were fertilized in the placebo group. With regards to the oocytes quality, better data were obtained in the myo-inositol group. More metaphase II and I oocytes were retrieved in relation to the total number of oocytes, when compared with the placebo group. Also, more embryos of grade I quality were observed in the myo-inositol group than in the placebo group. The duration of stimulation was 9.7 days (±3.3) in the myo-inositol group and 11.2 (±1.8) days in the placebo group and the number of used follicle-stimulating hormone (FSH) units was lower in the myo-inositol group in comparison to the placebo group: 1850 FSH units (mean) versus 1850 units (mean). Discussion Myo-inositol has proven to be a new treatment option for patients with PCOS and infertility. The achieved pregnancy rates are at least in an equivalent or even superior range than those reported using metformin as an insulin sensitizer. No moderate to severe side effects were observed when myo-inositol was used at a dosage of 4000 mg per day. In addition, our evidence suggests that a myo-inositol therapy in women with PCOS results in better fertilization rates and a clear trend to a better embryo quality. As by the same way the number of retrieved oocytes was smaller in the myo-inositol group, the risk of a hyperstimulation syndrome in these patients can be reduced. Therefore, myo-inositol also represents an improvement in IVF protocols for patients with PCOS.

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  • Authors+Show Affiliations

    ,

    Exeltis West Europe, Adalperostr. 84, 85737 Ismaning, Germany, Phone: +4989452052919, Fax: +49894520529819.

    ,

    Institut für medizinische Forschung Essen, 45122 Essen, Germany.

    ,

    Centre for Reproductive Medicine Bogenhausen, Munich, 81675 Munich, Germany.

    ANEMO, Nice, France.

    Source

    MeSH

    Disease Management
    Female
    Fertilization in Vitro
    Folic Acid
    Glucose
    Humans
    Infertility, Female
    Inositol
    Insulin
    Metabolic Networks and Pathways
    Polycystic Ovary Syndrome
    Pregnancy
    Pregnancy Outcome
    Pregnancy Rate
    Signal Transduction
    Treatment Outcome

    Pub Type(s)

    Journal Article
    Review

    Language

    eng

    PubMed ID

    29498933

    Citation

    Regidor, Pedro-Antonio, et al. "Management of Women With PCOS Using Myo-inositol and Folic Acid. New Clinical Data and Review of the Literature." Hormone Molecular Biology and Clinical Investigation, vol. 34, no. 2, 2018.
    Regidor PA, Schindler AE, Lesoine B, et al. Management of women with PCOS using myo-inositol and folic acid. New clinical data and review of the literature. Horm Mol Biol Clin Investig. 2018;34(2).
    Regidor, P. A., Schindler, A. E., Lesoine, B., & Druckman, R. (2018). Management of women with PCOS using myo-inositol and folic acid. New clinical data and review of the literature. Hormone Molecular Biology and Clinical Investigation, 34(2), doi:10.1515/hmbci-2017-0067.
    Regidor PA, et al. Management of Women With PCOS Using Myo-inositol and Folic Acid. New Clinical Data and Review of the Literature. Horm Mol Biol Clin Investig. 2018 Mar 2;34(2) PubMed PMID: 29498933.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Management of women with PCOS using myo-inositol and folic acid. New clinical data and review of the literature. AU - Regidor,Pedro-Antonio, AU - Schindler,Adolf Eduard, AU - Lesoine,Bernd, AU - Druckman,Rene, Y1 - 2018/03/02/ PY - 2017/10/09/received PY - 2018/01/15/accepted PY - 2018/3/3/pubmed PY - 2018/10/20/medline PY - 2018/3/3/entrez KW - PCOS KW - infertility KW - metabolic changes KW - myo-inositol JF - Hormone molecular biology and clinical investigation JO - Horm Mol Biol Clin Investig VL - 34 IS - 2 N2 - Introduction The use of 2 × 2000 mg myo-inositol +2 × 200 μg folic acid per day is a safe and promising tool in the effective improvement of symptoms and infertility for patients with polycystic ovary syndrome (PCOS). In addition, PCOS is one of the pathological factors involved in the failure of in vitro fertilization (IVF). Typically, PCOS patients suffer of poor quality oocytes. Patients and methods In an open, prospective, non-blinded, non-comparative observational study, 3602 infertile women used myo-inositol and folic acid between 2 and 3 months in a dosage of 2 × 2000 mg myo-inositol +2 × 200 μg folic acid per day. In a subgroup of 32 patients, hormonal values for testosterone, free testosterone and progesterone were analyzed before and after 12 weeks of treatment. The mean time of use was 10.2 weeks. In the second part of this trial it was investigated if the combination of myo-inositol + folic acid was able to improve the oocyte quality, the ratio between follicles and retrieved oocytes, the fertilization rate and the embryo quality in PCOS patients undergoing IVF treatments. Twenty-nine patients with PCOS, underwent IVF protocols for infertility treatment and were randomized prospectively into two groups. Group A (placebo) with 15 patients and group B (4000 mg myo-inositol +400 μg folic acid per day) with 14 patients were evaluated. The patients of group B used 2 months' myo-inositol + folic acid before starting the IVF protocol. For statistically analyses Student's t-test was performed. Results Seventy percent of the women had a restored ovulation, and 545 pregnancies were observed. This means a pregnancy rate of 15.1% of all the myo-inositol and folic acid users. In 19 cases a concomitant medication with clomiphene or dexamethasone was used. One twin pregnancy was documented. Testosterone levels changed from 96.6 ng/mL to 43.3 ng/mL and progesterone from 2.1 ng/mL to 12.3 ng/mL in the mean after 12 weeks of treatment (p < 0.05) Student's t-test. No relevant side effects were present among the patients. The women in the IVF treatment the group A showed a higher number of retrieved oocytes than group B. Nevertheless, the ratio follicle/retrieved oocyte was clearly better in the myo-inositol group (= group B). Out of the 233 oocytes collected in the myo-inositol group, 136 where fertilized whereas only 128 out of 300 oocytes were fertilized in the placebo group. With regards to the oocytes quality, better data were obtained in the myo-inositol group. More metaphase II and I oocytes were retrieved in relation to the total number of oocytes, when compared with the placebo group. Also, more embryos of grade I quality were observed in the myo-inositol group than in the placebo group. The duration of stimulation was 9.7 days (±3.3) in the myo-inositol group and 11.2 (±1.8) days in the placebo group and the number of used follicle-stimulating hormone (FSH) units was lower in the myo-inositol group in comparison to the placebo group: 1850 FSH units (mean) versus 1850 units (mean). Discussion Myo-inositol has proven to be a new treatment option for patients with PCOS and infertility. The achieved pregnancy rates are at least in an equivalent or even superior range than those reported using metformin as an insulin sensitizer. No moderate to severe side effects were observed when myo-inositol was used at a dosage of 4000 mg per day. In addition, our evidence suggests that a myo-inositol therapy in women with PCOS results in better fertilization rates and a clear trend to a better embryo quality. As by the same way the number of retrieved oocytes was smaller in the myo-inositol group, the risk of a hyperstimulation syndrome in these patients can be reduced. Therefore, myo-inositol also represents an improvement in IVF protocols for patients with PCOS. SN - 1868-1891 UR - https://www.unboundmedicine.com/medline/citation/29498933/Management_of_women_with_PCOS_using_myo_inositol_and_folic_acid__New_clinical_data_and_review_of_the_literature_ L2 - https://www.degruyter.com/doi/10.1515/hmbci-2017-0067 DB - PRIME DP - Unbound Medicine ER -