Myo-Inositol + Letrozole for PCOS Infertility
Palo Alto (17 mi)Overseen byHeather Burks, MD
Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of Oklahoma
Trial Summary
What is the purpose of this trial?This will be a prospective, double-blind randomized clinical trial of letrozole and placebo versus letrozole and inositols for up to 5 treatment cycles of ovulation induction or until pregnancy is achieved. All participants and members of the research team will be blinded to the treatment arms. Placebo and inositol supplement will be packaged to appear the same, tested, and packaged by a commercial supply company. The inositols will be a 40:1 blend of myo-inositol and D-chiro inositol.
Is the treatment Inositol supplement a promising treatment for PCOS infertility?Yes, the Inositol supplement is a promising treatment for PCOS infertility. It helps improve ovarian function, enhances fertility, and positively affects hormonal and metabolic aspects in women with PCOS.34789
What safety data exists for Myo-Inositol and Letrozole treatment in PCOS infertility?The studies reviewed indicate that Myo-Inositol, alone or combined with D-Chiro-Inositol, is effective in improving ovarian function and metabolic profiles in women with PCOS. The meta-analysis of randomized controlled trials shows significant decreases in fasting insulin and HOMA index, suggesting a positive impact on metabolic parameters. No specific safety concerns were highlighted in these studies, suggesting that Myo-Inositol is generally well-tolerated. However, the safety of combining Myo-Inositol with Letrozole specifically was not directly addressed in the provided studies.13678
Do I have to stop taking my current medications?The trial requires you to stop using myo-inositol at least 3 months before enrolling and metformin at least 6 weeks before randomization. Other medications are not specified, so check with the trial team.
What data supports the idea that Myo-Inositol + Letrozole for PCOS Infertility is an effective treatment?The available research shows that Myo-Inositol, when used alone or with D-Chiro-Inositol, can help women with PCOS by improving their hormone levels and metabolism. One study found that Myo-Inositol significantly reduced insulin levels and improved a measure of insulin resistance. Another study showed that Myo-Inositol helped reduce the rate of treatment cancellations and increased pregnancy rates in women undergoing a specific fertility treatment. While Myo-Inositol alone did not significantly improve egg or embryo quality, it did show some benefits in other areas, suggesting it can be a helpful part of a treatment plan for PCOS infertility.12356
Eligibility Criteria
This trial is for women aged 18-36 who want to get pregnant but are dealing with infertility due to polycystic ovary syndrome (PCOS). They should have irregular or no ovulation, at least one open fallopian tube, a normal uterus, and a partner with sufficient sperm count. Women can't join if they've taken myo-inositol recently, used metformin within the last 6 weeks, have diabetes or other causes of infertility.Inclusion Criteria
My uterine cavity is normal.
I am a woman aged between 18 and 36.
My male partner has a sperm count of at least 14 million/mL.
I have at least one open fallopian tube.
I have PCOS with irregular periods and either high male hormones or many small cysts on my ovaries.
Exclusion Criteria
My ovulation issues are not due to PCOS but another untreated condition.
I have diabetes.
Treatment Details
The study tests whether adding an inositol supplement to letrozole treatment improves fertility in PCOS patients compared to letrozole alone. Participants will receive either a placebo or an inositol blend without knowing which one until the end of up to five treatment cycles or until pregnancy occurs.
2Treatment groups
Active Control
Placebo Group
Group I: Inositol ArmActive Control1 Intervention
This group will receive myo-inositol (2,000mg) plus d-chiro-inositol (50mg) supplement powder twice daily.
Group II: Control ArmPlacebo Group1 Intervention
This group will receive placebo powder twice daily.
Inositol supplement is already approved in European Union, United States, Canada for the following indications:
πͺπΊ Approved in European Union as Myo-Inositol for:
- Polycystic ovary syndrome (PCOS)
- Infertility
πΊπΈ Approved in United States as Myo-Inositol for:
- Polycystic ovary syndrome (PCOS)
- Infertility
π¨π¦ Approved in Canada as Myo-Inositol for:
- Polycystic ovary syndrome (PCOS)
- Infertility
Find a clinic near you
Research locations nearbySelect from list below to view details:
OUHSC Reproductive Medicine ClinicOklahoma City, OK
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Who is running the clinical trial?
University of OklahomaLead Sponsor
References
Myo-inositol administration positively affects hyperinsulinemia and hormonal parameters in overweight patients with polycystic ovary syndrome. [2022]To evaluate the effects the administration of myo-inositol (MYO) on hormonal parameters in a group of PCOS patients.
The role of inositol supplementation in patients with polycystic ovary syndrome, with insulin resistance, undergoing the low-dose gonadotropin ovulation induction regimen. [2013]In an attempt to evaluate the role of inositol supplementation in insulin-resistant patients with polycystic ovary syndrome (PCOS), undergoing gonadotropin ovulation induction using the low-dose step-down regimen, we conducted a prospective longitudinal study comparing the stimulation characteristics of 15 patients treated with inositol, to a cohort, matched by age and body mass index (BMI), without inositol. Inositol nutritional supplementation produced very good clinical results with a significant reduction in cancellation rate (0 vs. 40%) and the consequent improvement in clinical pregnancy rate (PR) (33.3% vs. 13.3%).
Comparison between effects of myo-inositol and D-chiro-inositol on ovarian function and metabolic factors in women with PCOS. [2014]Myo-inositol and D-chiro-inositol are capable of improving the ovarian function and metabolism of polycystic ovary syndrome (PCOS) patients. The aim of this work is to compare the effects of myo-inositol and D-chiro-inositol in PCOS. We enrolled 50 patients, with homogeneous bio-physical features, affected by PCOS and menstrual irregularities, and we randomly divided them into two groups: 25 were treated with 4 g of myo-inositol/die plus 400 mcg of folic acid/die orally for six months, 25 with 1 g of D-chiro-inositol/die plus 400 mcg of folic acid/die orally for six months. We analyzed in both groups pre-treatment and post-treatment BMI, systolic and diastolic blood pressure, Ferriman-Gallwey score, Cremoncini score, serum LH, LH/FSH ratio, total and free testosterone, dehydroepiandrosterone sulfate (DHEA-S), Ξ-4-androstenedione, SHBG, prolactin, glucose/immunoreactive insulin (IRI) ratio, homeostatic model assessment (HOMA) index, and the resumption of regular menstrual cycles. Both the isoforms of inositol were effective in improving ovarian function and metabolism in patients with PCOS, although myo-inositol showed the most marked effect on the metabolic profile, whereas D-chiro-inositol reduced hyperandrogenism better.
A Combined Therapy with Myo-Inositol and D-Chiro-Inositol Improves Endocrine Parameters and Insulin Resistance in PCOS Young Overweight Women. [2020]Introduction. We evaluated the effects of a therapy that combines myo-inositol (MI) and D-chiro-inositol (DCI) in young overweight women affected by polycystic ovary syndrome (PCOS), characterized by oligo- or anovulation and hyperandrogenism, correlated to insulin resistance. Methods. We enrolled 46 patients affected by PCOS and, randomly, we assigned them to two groups, A and B, treated, respectively, with the association of MI plus DCI, in a 40 : 1 ratio, or with placebo (folic acid) for six months. Thus, we analyzed pretreatment and posttreatment FSH, LH, 17-beta-Estradiol, Sex Hormone Binding Globulin, androstenedione, free testosterone, dehydroepiandrosterone sulphate, HOMA index, and fasting glucose and insulin. Results. We recorded a statistically significant reduction of LH, free testosterone, fasting insulin, and HOMA index only in the group treated with the combined therapy of MI plus DCI; in the same patients, we observed a statistically significant increase of 17-beta-Estradiol levels. Conclusions. The combined therapy of MI plus DCI is effective in improving endocrine and metabolic parameters in young obese PCOS affected women.
Inositol supplementation in women with polycystic ovary syndrome undergoing intracytoplasmic sperm injection: a systematic review and meta-analysis of randomized controlled trials. [2018]Polycystic ovary syndrome (PCOS) is a complex and heterogeneous disease that involves menstrual dysfunction and reproductive difficulty, as well as metabolic problems. The aim of this study was to assess the effectiveness of myo-inositol (MYO) and d-chiro-inositol (DCI) on improving oocyte or embryo quality and pregnancy rates for women with PCOS undergoing intracytoplasmic sperm injection (ICSI). We searched the Web of Knowledge, MEDLINE, EMBASE, Pubmed, Scopus and Cochrane databases for all articles published in any language up to March 2017. The selection criteria were as follows: (population) patients with PCOS; (intervention) treatment with inositol (MYO, DCI, or both, with any dose and any duration) in conjunction with an ovulation-inducing agent versus the ovulation-inducing agent alone; (outcome) oocyte and embryo quality; (study design) randomized controlled trials. Of 76 identified studies, eight RCTs were included for analysis comprising 1019 women with PCOS. MYO supplementation was insufficient to improve oocyte quality (OR 2.2051; 95% CI 0.8260 to 5.8868), embryo quality (OR 1.6231, 95% CI 0.3926 to 6.7097), or pregnancy rate (OR 1.2832, 95% CI 0.8692 to 1.8944). Future studies of appropriate dose, size and duration of DCI are vital to clarify its the role in the management of PCOS.
Myo-inositol effects in women with PCOS: a meta-analysis of randomized controlled trials. [2020]Myo-inositol (MI) supplementation in women with polycystic ovary syndrome (PCOS) has been evaluated over the last years. Many hormonal and reproductive impairments associated with this disorder seem relieved by the supplement. The objective of the meta-analysis was to assess the effects of MI alone or combined with d-chiro-inositol (DCI) on the endocrine and metabolic abnormalities of women with PCOS. Literature was retrieved from selected databases, MEDLINE, EMBASE, PubMed and Research Gate (up to November 2016). Only randomized controlled trials (RCTs) investigating the effects of MI alone or combined with DCI were reviewed. Nine RCTs involving 247 cases and 249 controls were included. Significant decreases in fasting insulin (SMD = -1.021 µU/mL, 95% CI: -1.791 to -0.251, P = 0.009) and homeostasis model assessment (HOMA) index (SMD = -0.585, 95% CI: -1.145 to -0.025, P = 0.041) were identified after MI supplementation. The trial sequential analysis of insulin meta-analysis illustrates that the cumulative z-curve crossed the monitoring boundary, providing firm evidence of the intervention effect. A slight trend toward a reduction of testosterone concentration by MI with respect to controls was found (SMD = -0.49, 95% CI: -1.072 to 0.092, P = 0.099), whereas androstenedione levels remained unaffected. Throughout a subgroup's meta-analysis, a significant increase in serum SHBG was observed only in those studies where MI was administered for at least 24 weeks (SMD = 0.425 nmol/L, 95% CI: 0.050-0.801, P = 0.026). These results highlight the beneficial effect of MI in improving the metabolic profile of women with PCOS, concomitantly reducing their hyperandrogenism.
Metabolic and hormonal effects of a combined Myo-inositol and d-chiro-inositol therapy on patients with polycystic ovary syndrome (PCOS). [2020]To evaluate the effects of a combined Myo-inositol (MI) and D-chiro-inositol (DCI) therapy on the hormonal and metabolic parameters of women with PCOS. Prospective clinical study. Clinical Study registration number - EUPAS25705 Material and methods: Seventy women diagnosed with PCOS according to the Rotterdam criteria were enrolled in this study. Patients received a combined therapy of one tablet that contained 550 mg of inositol (myo-inositol (MI) and D-chiro-inositol (DCI) in a ratio of 10:1) twice a day for 6 months. At each of 3 visits, the body weight, height and BMI were all recorded; and serum levels of free testosterone (fT), sex hormone-binding globulin (SHBG), luteinizing hormone (LH), follicle-stimulating hormone (FSH) and glucose with insulin during standard OGTT (75 g) were measured. Also at each visit, transvaginal ultrasonography and skin condition assessments were performed.
The effectiveness of inositol and metformin on infertile polycystic ovary syndrome women with resistant to letrozole. [2020]The purpose is a comparison of effectiveness of myo-inositol and metformin in infertile women with polycystic ovary syndrome (PCOS) treated with letrozole.
Inositols in PCOS. [2023](1) Background: Myoinositol (MI) and D-chiro-inositol (DCI) are involved in a number of biochemical pathways within oocytes having a role in oocyte maturation, fertilization, implantation, and post-implantation development. Both inositols have a role in insulin signaling and hormonal synthesis in the ovaries. (2) Methods: Literature search (with key words: inositols, myo-inositol, d-chiro-inositol, PCOS) was done in PubMed until Sept. 2020 and 197 articles were identified, of which 47 were of clinical trials (35 randomized controlled trials). (3) Results: Many studies have demonstrated that in patients with polycystic ovarian syndrome (PCOS) MI treatment improved ovarian function and fertility, decreased the severity of hyperandrogenism including acne and hirsutism, positively affected metabolic aspects, and modulated various hormonal parameters deeply involved in the reproductive axis function and ovulation. Thus treating with MI has become a novel method to ameliorate PCOS symptoms, improve spontaneous ovulation, or induce ovulation. The current review is focused on the effects of MI and DCI alone or in combination with other agents on the pathological features of PCOS with focus on insulin resistance and adverse metabolic outcomes. (4) Conclusions: The available clinical data suggest that MI, DCI, and their combination in physiological ratio 40:1 with or without other compound could be beneficial for improving metabolic, hormonal, and reproductive aspects of PCOS.