O-151 Endometrial preparation using CONCEIVF algorithm with intrauterine and sub-endometrial endosera administration for enhanced pregnancy rates in women with thin endometrium

Abstract

Abstract Study question Could personalized regenerative medicine based strategies promote endometrial growth and receptivity in women with refractory thin endometrium resulting in successful implantation and live births? Summary answer Personalized regenerative medicine based strategies remarkably promote endometrial growth and receptivity in women with refractory thin endometrium resulting in successful implantation and live births What is known already Thin endometrium (<7mm) is considered sub-optimal for embryo transfer and associated with reduced pregnancy chances. Regenerative medicine based strategies utilizing stem cells, growth factors alone or in combination for endometrial regeneration have been proposed as futuristic clinical therapies. Data-intensive biomedical technologies in research studies reveals that humans vary widely at genetic, biochemical, physiological, exposure and behavioral levels, especially with respect to disease processes and treatment responsiveness. Hence there is a need to deeply ‘personalize,’ interventional strategies at clinical and dosage level for individual patients. Study design, size, duration In this self- controlled study, 60 women with history of more than 3 failed IVF cycles due to persistent refractory thin endometrium (<7mm) were enrolled between July 21-December 23. 42 women were treated with intrauterine administration of Endosera and 18 patients were treated with sub-endometrial administration of Endosera as suggested by CONCEIVF - Proprietary Algorithm from Seragen.. Endosera is Autologous platelet derived implantation friendly anti-inflammatory cytokines and concentrated growth factors and progenitor cells. Participants/materials, setting, methods CONCEIVF-Algorithm classifies patients (High, Moderate, Poor responders) based on age, BMI, clinical history, guiding standardized dosage routines for proliferative, secretory, implantation phases including CD 33/CD34 cells minimal threshold, are specified. Intrauterine Endosera administration, 2 or 3 times from menstrual cycle day 5 during FET, precedes embryo transfer. Sub-endometrial administration involves Endosera with endothelial progenitor cell support on cycle days 5-7, followed by embryo transfer two days after the final Endosera infusion in the subsequent cycle. Main results and the role of chance Clinical pregnancy rate was 77%(46/60), no pregnancy in 10 patients accounting for 17%. 50% (30/60) delivered healthy babies and 17%(10/60) of uneventful pregnancies are progressing. 3 patients (5%) had miscarriage between 6-8 weeks. Improvement in endometrium thickness (EMT) was 90% with mean difference of 1.9mm improvement in 54 patients. No adverse effects reported. 33 patients out of 42 conceived and 6 out of 42 patients did not conceive and 3 out of 42 patients are yet to undergo embryo transfer in the intra-uterine group. 13 patients out of 18 conceived and 4 out of 18 patients did not conceive and 1 out of 18 patient is yet to undergo embryo transfer in the sub-endometrial group. Live birth rate and on-going pregnancies are indicators of overall endometrial quality (thickness and receptivity) improvement and validates that personalization helps to achieve maximum success rate. 15 out of 60 patients who were referred to surrogacy have conceived. In women with a history of cycle cancellations due to thin endometrium, CONCEIVF algorithm recommended personalized Endosera dosages resulted in improved endometrial thickness, clinical pregnancy and live birth. Personalization holds the key for precision because now two patients are alike! Limitations, reasons for caution This prospective self-control study, contains small sample size and lacks randomized controlgroup. Our results are encouraging but large cohort of patients is needed to establish efficacy. of protocols and positive patient predictors score to strengthen Conceivf personalized recommendations. Wider implications of the findings Despite global rise in FET for diverse indications, ongoing efforts to find the optimal endometrial preparation protocol persist. Our personalized approach achieved cumulative 74% pregnancy rate (40/54 ETs done), inspiring planned randomized trials to validate results and help women with resistant thin endometrium to conceive without surrogacy. Trial registration number Not applicable