The effect of myo‐inositol/di‐chiro‐inositol on markers of ovarian reserve in women with PCOS undergoing IVF/ICSI: A systematic review and meta‐analysis: ribociclib
Summary
Scientific Summary: Ribociclib
Introduction
The provided text does not directly discuss ribociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor used primarily in the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. Instead, the text focuses on the effects of inositol isomers (myo-inositol [MI] and D-chiro-inositol [DCI]) on reproductive outcomes and ovarian markers in women with polycystic ovary syndrome (PCOS) undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Since there is no information on ribociclib in the provided text, this summary will comprehensively synthesize the available data on inositols in the context of PCOS and fertility treatment, as detailed in the systematic review and meta-analysis cited.
Overview of Study Focus
Objective
The primary objective of the systematic review was to evaluate the effect of MI/DCI treatment on markers of ovarian reserve in women with PCOS, compared to no treatment, placebo, or other interventions. The secondary aim was to assess the impact of these treatments on reproductive outcomes in women with PCOS undergoing IVF/ICSI procedures (Bhide et al., 2019).
Study Characteristics
- Number of studies included: 12 (7 on ovarian reserve markers, 9 on reproductive outcomes)
- Design: 2 randomized controlled trials (RCTs), 5 non-randomized studies, all single-center
- Sample size: 415 women with PCOS
- Geographic distribution: Predominantly Italy, with studies from Turkey and Georgia
Key Findings
1. Ovarian Reserve Markers
- The review found no adequate evidence for changes to the antral follicle pool following the use of inositols.
- Meta-analysis of studies reporting the number of retrieved oocytes (7 RCTs, 722 participants):
- No statistically significant difference between intervention and control arms (Mean Difference [MD] −0.39, 95% Confidence Interval [CI] −1.11 to 0.33).
- Subgroup analysis:
- MI: MD −0.76, 95% CI −2.04 to 0.52
- DCI: MD −0.18, 95% CI −1.11 to 0.74
- Some individual studies reported conflicting results:
- Piomboni et al. reported a significantly higher number of MII oocytes with DCI (MD 1.30, 95% CI 0.15-2.45)
- Ciotta et al. found more oocytes with MI (P < 0.05)
- Lesoine & Regidor found more oocytes in the control group
2. Reproductive Outcomes after IVF/ICSI
- Clinical pregnancy rate:
- Meta-analysis of 3 RCTs (488 participants): No significant difference (Relative Risk [RR] 1.16, 95% CI 0.87-1.53).
- No significant differences between MI and DCI groups.
- Live birth rate:
- Only one trial (Artini et al.) reported a significant improvement in live birth rate with MI (P < 0.05).
- Cycle cancellation due to OHSS:
- Six studies reported on this outcome, but detailed aggregate data were not specified in the summary.
3. Safety and Adverse Effects
- Inositols are available over-the-counter and have a minimal burden of adverse effects.
- Their insulin pathway modulation may theoretically reduce risks in PCOS patients undergoing assisted reproduction.
Methodological Quality and Bias
- Risk of bias:
- Most included studies had moderate risks of bias, with many lacking details on randomization, allocation concealment, and blinding.
- Non-randomized studies were generally at moderate risk of bias according to the ROBINS-I tool.
- The heterogeneity of study populations, interventions, and outcome definitions further limits the robustness of conclusions.
Conclusions
- No robust or consistent evidence supports the use of MI or DCI as pretreatment to improve reproductive outcomes or safety in women with PCOS undergoing IVF/ICSI.
- No significant effect on the number of oocytes retrieved or clinical pregnancy rates was observed.
- Live birth data are limited, with only a single trial suggesting benefit.
- Safety profile is favorable, but efficacy remains unproven based on current evidence.
Implications for Clinical Practice
Given the lack of high-quality evidence and the inconsistent direction and magnitude of observed effects, the routine use of MI or DCI as pretreatment in PCOS patients seeking assisted reproduction cannot be recommended at this time. Further large, well-designed RCTs are needed to clarify these agents' potential roles.
References
Note: The original user's query regarding "ribociclib" cannot be addressed with the provided text, as it contains no references to ribociclib or CDK4/6 inhibitors. The summary above is a comprehensive synthesis of the available information on inositols in PCOS-related infertility, as per the supplied content.
REFERENCES
Bhide, Priya et al. "The effect of myo‐inositol/di‐chiro‐inositol on markers of ovarian reserve in women with