Effects of Oral Inositol Supplementation on Spontaneous Reproductive Outcomes in Infertile Polycystic Ovarian Syndrome Women.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Miscarriage rate
研究概览
简要总结
Polycystic ovarian syndrome (PCOS) is a heterogeneous, multifaceted and complex disorder characterized by insulin resistance (IR), hyperinsulinemia, and hyperandrogenism leading ovarian disfunction and infertility. Given the central pathogenic role of IR in the endocrine, reproductive, and metabolic disturbances of PCOS, several pharmacological and non-pharmacological approaches have been proposed to counteract the hyper insulinemic IR typical of the syndrome. Two Inositol stereoisomers, Myo-Inositol (MI) and D-chiro-inositol (DCI), captured the attention of researchers for their insulin-sensitizing actions, which configure them as proper candidates for the treatment of PCOS.
Very few studies reported on spontaneous clinical pregnancy rates, none were powered for this outcome, and none reported on the clinically relevant outcome of live birth. Therefore, data about clinical pregnancy rate, live birth rate, and miscarriage rate comparing inositols with placebo are limited.
Conversely, about infertility and assisted reproduction techniques (ART), improvements have been reported in PCOS women who underwent fertility treatment using inositol in different forms, combinations or doses. This data, considering the different tissue-specific ratios (i.e., 100:1 in the ovary) and the different physiological roles of inositol stereoisomers, suggest that DCI supplementation alone might not be the optimal or appropriate approach for improving IVF outcomes in PCOS patients, and drawn attention to the importance of MI and DCI supplementation in a physiological ratio in order to restore normal ovary functionality. Indeed, the combination of MI and DCI, at a more physiological ratio of 40:1, was able to more quickly restore to normal the hormonal and metabolic parameters in PCOS women than MI treatment alone or DCI treatment alone, improving the endocrine profile and IR of women with PCOS.
Nevertheless, regarding infertility the primary outcomes that should be considered are clinical pregnancy rate, miscarriage rate and live birth rate. Although many studies showed improved hormonal and metabolic profile and improved ovulation rate and higher quality and number of oocyte retrieved in ART in PCOS women after inositols administration, data about clinical pregnancy rate, live birth rate, and miscarriage rate are limited with several concerns regarding interpretation of the studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patients, care provides, investigators and outcome assessors are blinded for the treatment: Inositol + Folic acid versus Folic acid alone. The treatment allocation is identified by code number before the study start, and will be revealed only after data analysis.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with PCOS diagnosed by Rotterdam criteria in couple that desire to conceive.
排除标准
- •Male infertility factor that require in vitro fertilization technique.
- •Women with infertility factors that require in vitro fertilization technique.
- •Couple with infertility factors that require in vitro fertilization technique.
- •Diabetes mellitus that require insulin or oral drugs treatment.
- •Any other pre-pregnancy or pregnancy-induced/related disease.
- •Any other pharmacological, non-pharmacological or nutraceutical treatment (beside oral folic acid supplementation) more than 3 months before the enrollment (wash-out period) or during the trial.
结局指标
主要结局
Miscarriage rate
时间窗: Within 6 months from the enrollment
Number of spontaneous abortion per women diagnosed by positive pregnancy test with subsequent spontaneous interruption of the pregnancy.
Live birth rate
时间窗: Within 18 months from the enrollment
Number of spontaneous pregnancies per women resulted in a delivered viable fetus.
Clinical pregnancy rate
时间窗: Within 6 months from the enrollment
Number of spontaneous pregnancies conceived per women diagnosed by transvaginal ultrasound. Diagnosis is based on the identification of intrauterine gestational sac with embryo and/or yolk sac.
Spontaneous ovulation rate
时间窗: Change in spontaneous ovulation rate, through study completion (an average of 18 months)
Spontaneous ovulation activity evaluated by menstrual cycle regularization. Menstrual cycles evaluated by intervals between menstruations (days), day of menstrual blood flow. Rate evaluate considering the number of women with restored regular menstrual cycles per women with irregular menstrual cycles.
次要结局
- Glucose metabolism(Change in glucose metabolism, through study completion (an average of 18 months))
- BMI(Change in BMI, through study completion (an average of 18 months))
- Lipid metabolism(Change in Lipid metabolism, through study completion (an average of 18 months))
- Androgens profile(Change in Androgens profile, through study completion (an average of 18 months))
- Blood pressure(Change in Blood pressure, through study completion (an average of 18 months))
研究者
Antonio Simone Laganà
Principal Investigator
Università degli Studi dell'Insubria