A Randomized Clinical Trial to Compare the Efficacy of Phala Ghrita Uttarabasti and Brihat Shatavari Ghrita Uttarabasti on Endometrial receptivity in Unexplained Infertility

1.   Infertility affects a significant number of couples worldwide, and for about 10-30% of them, the reason remains unknown – a condition called unexplained infertility . One of the key issues in infertility, including unexplained infertility, can be problems with the endometrium, which is the lining of the uterus. For a pregnancy to occur, an embryo needs to successfully attach to a healthy and receptive endometrium. One important factor for this attachment is a protein called alpha V beta 3 integrin, which is found in the uterine lining. Studies have shown that women who have trouble with implantation often have lower levels of this protein. Ayurveda offers various treatments for infertility, and one such method is Uttarabasti. This involves administering medicated oils or ghee directly into the uterus. This study aims to investigate two specific Ayurvedic preparations, Phala Ghrita and Brihat Shatavari Ghrita, administered via Uttarabasti. These preparations have been used in Ayurveda to improve fertility and reproductive health. Currently, there’s limited scientific evidence to explain how these Ayurveda treatments work at a molecular level. This research seeks to bridge that gap by scientifically comparing the effects of Phala Ghrita Uttarabasti and Brihat Shatavari Ghrita Uttarabasti on improving endometrial receptivity and, specifically, the expression of alpha V beta 3 integrin in women with unexplained infertility. The study will involve 80 women (40 in each group) aged 20-40 with unexplained infertility. They will receive either Phala Ghrita or Brihat Shatavari Ghrita via Uttarabasti for six days after their period, for three cycles. Researchers will assess changes in their endometrial receptivity using a scoring system and measure the expression of alpha V beta 3 integrin in their endometrial tissue before and after the treatment. The study will also monitor for any potential side effects. The goal is to see if these Ayurvedic interventions can improve the endometrial receptivity, specifically by enhancing the expression of alpha V beta 3 integrin, and ultimately increase the chances of successful embryo implantation for women with unexplained infertility. If successful, this study could offer a new, holistic treatment option, combining traditional wisdom with modern scientific understanding to help couples struggling to conceive. The study will be conducted over 30 months and will only begin after receiving ethical approval and registration.