Abstract
Abstract Study question Can Autologous Platelet Derived Growth Factors (hereafter EndoSERA) be used as promising coadjuvant therapy in assisted reproductive techniques to improve endometrial thickness and implantation rate? Summary answer Use of EndoSERA significantly increased endometrial growth, clinical pregnancy and Live Birth Rate In Patients With refractory thin endometrium during FET cycles. What is known already Inadequate endometrial thickness and receptivity are major causes for RIF and surrogacy is reasonable option when endometrium remains unresponsive to conventional treatments. Recent studies demonstrated platelet-rich plasma (PRP) improves pregnancy outcomes in thin endometrium and RIF patients. The mechanisms of PRP have not been completely elucidated, but laboratory studies have shown that the high concentration of growth factors in PRP can potentially speed up the healing process. Need for an optimized method to ensure right concentration of platelets and growth factors to maximize the therapeutic outcomes formed the basis for developing EndoSERA-implantation friendly platelet derived growth factors concentrate. Study design, size, duration In this prospective interventional self-controlled study, 55 women in the age group of 25-45 years from July 2018 to July 2022 with > 3 failed FET due to refractory thin endometrium, negative hysteroscopic screening for endometrial pathology, and negative bacteriologic screening and failed to get pregnant with multiple immune therapy regimens like intralipid infusions, granulocyte colony-stimulating factor infusions, steroid therapy, endometrial scratching were selected to undergo Endo-SERA treatment. Participants/materials, setting, methods After obtaining informed consent subjects were treated with intrauterine infusion of EndoSERA 3 times (Day7 and Day 12 of their menstrual cycle day and 2 days before ET). 54 patients underwent FET. Intrauterine infusion of 0.8 ml of EndoSERA was infused into uterine cavity in addition to standard HRT protocols. Clinical pregnancy was determined by positive serum β-HCG, 2weeks after ET and presence of fetal heart beat in trans-vaginal ultrasound 5weeks after ET. Main results and the role of chance Post EndoSERA administration endometrial thickness(ET) was significantly thicker (7.86 ± 0.22 vs 6.22 ± 0.31 mm; P <.05) in 98% of patients and optimal response to EndoSERA was considered to reach ET ≥ 7mm after 2nd EndoSERA dose administration. Only one patient’s cycle got canceled due to ET < 7mm. Out of 55 women, 42 became pregnant (76%) and 12 patients did not conceive (22%). 39 women (70.9%) had a clinical pregnancy and 5 women (9.1%) miscarried before 6-12 wks and 3 women (5%) had biochemical pregnancy. 33 women (60%) had delivered healthy full-term babies and one patient (2%) is in her 24th week of uneventful gestation. There were no adverse effects reported by the patients who were treated with EndoSERA. There are studies highlighting the need for an angiogenic and anti-inflammatory environment for successful implantation. EndoSERA is standardized to contain 6-9 folds higher amounts of growth factors than peripheral blood majorly implantation friendly and anti-inflammatory cytokines which restore impaired uterine environments and optimized for cyclical requirements of proliferation, secretion & Implantation phases of Endometrium. It has also been shown to be safe, reproducible, and effective in mimicking the natural processes of tissue repair and regeneration. Limitations, reasons for caution This prospective self-controlled study with small sample size lacks a randomized control group. While the beneficial effects observed in this study are improved than published data, larger study with patients recruited based on inclusion criteria of refractory thin endometrium is proposed for recommending EndoSERA as routine adjuvant during IVF procedures. Wider implications of the findings EndoSERA improved implantation, pregnancy, and live birth rates (LBR) in refractory thin endometrium patients which indicates clearly endometrial thickness and receptivity improvement and cumulative 62% has motivated us to plan randomized controlled studies to confirm the results and provide opportunity for women with refractory thin endometrium to conceive without surrogacy. Trial registration number Not Applicable
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