DefinePK

Research Objective

To compare the outcome of ovulation induction in clomiphene citrate (CC) alone and combined treatment with CC and pioglitazone in terms of mean maximum follicle size among infertile women with PCOS.

Methodology

This randomized controlled trial enrolled 274 married women with PCOS and infertility. Participants were randomized into two groups: Group A (CC alone, n=137) and Group B (CC + pioglitazone, n=137). Treatment involved escalating doses of CC (50mg, 100mg, 150mg) over three menstrual cycles, with Group B also receiving 30mg of pioglitazone daily from the third to seventh day of menstruation. Ultrasonographic folliculometry was performed until mature follicles (≥18 mm) were detected, followed by hCG injection. Mean maximum follicle size was recorded over three cycles. Data were analyzed using SPSS.

Methodology Flowchart

                        graph TD;
    A[Enroll Infertile Women with PCOS] --> B[Randomize into Two Groups];
    B --> C[Group A: CC Alone];
    B --> D[Group B: CC + Pioglitazone];
    C --> E[Administer CC escalating doses];
    D --> F[Administer CC + Pioglitazone];
    E --> G[Perform Folliculometry];
    F --> G;
    G --> H[Mature Follicle Detected?];
    H -- Yes --> I[Administer hCG];
    H -- No --> E;
    I --> J[Monitor Ovulation Signs];
    J --> K[Record Mean Maximum Follicle Size];
    K --> L[Analyze Data using SPSS];
    L --> M[Draw Conclusions];                    

Discussion

The combination of pioglitazone with clomiphene citrate significantly improved follicular development in infertile women with PCOS, as indicated by larger mean follicle sizes. This synergistic effect is attributed to pioglitazone's insulin-sensitizing properties, which may ameliorate insulin resistance, a key factor in PCOS pathophysiology. The combination therapy is presented as an economical and attainable treatment, particularly beneficial for resource-constrained settings. Limitations include data from a single institution, lack of pregnancy outcome data, and insufficient assessment of pioglitazone's adverse effects.

Key Findings

The mean maximum follicle size was significantly larger in the combination group (Group B: 21.48 ± 2.26 mm) compared to the CC alone group (Group A: 18.53 ± 3.31 mm) (p<0.001). This superiority of the combined treatment was consistent across various subgroups including age, BMI, residential status, duration of marriage, and type of infertility.

Conclusion

Combining clomiphene citrate with pioglitazone significantly enhances follicular growth in infertile women with PCOS. This approach offers a cost-effective, accessible, and scalable treatment option, especially valuable for resource-limited countries. Further research is recommended to evaluate long-term outcomes, cost-effectiveness, and safety profiles.

Fact Check

* Sample Size: A total of 274 infertile women with PCOS were enrolled and divided equally into two groups of 137 each.
* Mean Maximum Follicle Size (Group B): The mean maximum follicle size in the Clomiphene Citrate plus Pioglitazone group was 21.48 ± 2.26 mm.
* Mean Maximum Follicle Size (Group A): The mean maximum follicle size in the Clomiphene Citrate alone group was 18.53 ± 3.31 mm.

Mind Map