Vol. 2, Issue 2, Part A (2025)

Unexplained infertility affects a significant proportion of couples seeking reproductive assistance, with limited treatment options available beyond conventional assisted reproductive technologies (ART). This multicentric, randomised controlled clinical study aimed to evaluate the efficacy and safety of Phala-Vardhaka Yoga (PVY), an Ayurvedic formulation, as an adjunct to standard infertility care in women diagnosed with unexplained infertility. A total of 210 women were randomised to receive either PVY plus standard care or standard care alone over six treatment cycles. The primary outcome was clinical pregnancy rate, with secondary outcomes including ovulation rate, endometrial thickness, and live-birth rates. The results showed that the PVY group had a significantly higher clinical pregnancy rate (38.1% vs 21.9%; p=0.006) and live-birth rate (34.3% vs 19.0%; p=0.012) compared to the standard care group. Additionally, PVY was associated with higher ovulation rates (86.1% vs 73.8%, p=0.018) and greater improvement in endometrial thickness (9.5 mm vs 8.8 mm, p=0.003). The formulation was well tolerated, with mild, transient adverse events. These findings suggest that Phala-Vardhaka Yoga provides an effective, safe, and non-invasive adjunct to standard infertility treatments, particularly for women with unexplained infertility. The study supports the integration of Ayurvedic therapies into modern fertility care, offering a complementary option for those seeking alternative or adjunct treatments to ART.