P-329 Evaluating Implansera, autologous platelet-derived growth factors, to improve clinical pregnancy and live birth rates in frozen embryo transfer for women with recurrent implantation failure
Authors: Anitha D , Vasanthi P , Srinivas C 
Published: July 2024

Abstract

Study question
Can Implansera, Autologous Platelet-Derived Growth Factors, serve as a promising adjuvant therapy in assisted reproductive techniques to enhance endometrial thickness and implantation rates?

Summary answer
Use of Implansera significantly increased clinical pregnancy and Live Birth Rate In Patients With repeated implantation failure during FET cycles.

What is known already
Insufficient endometrial thickness and receptivity contribute to Recurrent Implantation Failure (RIF), prompting consideration of surrogacy. Despite global rise in Frozen Embryo Transfer (FET), quest for an optimal implantation protocol persists. Recent research highlights platelet-rich plasma (PRP) as promising solution for thin endometrium and RIF cases, attributing positive outcomes to PRP’s high growth factor concentration. Recognizing the need for precise platelet and growth factor concentrations, Implansera—a specialized platelet-derived growth factor concentrate—was developed. This innovation addresses the challenge of unresponsive endometrium, offering tailored solution to maximize therapeutic efficacy and improve pregnancy outcomes for patients facing RIF issues.

Study design, size, duration
Conducted from May 2021 to December 2023, this prospective interventional self-controlled study focused on 21 women (aged 30-48) experiencing recurrent IVF failure due to stubborn thin endometrium. Selected after negative hysteroscopic and bacteriologic screenings, and unsuccessful pregnancies despite multiple immune therapy regimens, such as intralipid and granulocyte colony-stimulating factor infusions, steroids, and endometrial scratching. The subjects underwent Implansera treatment, aiming to address refractory thin endometrium and potentially enhance their chances of successful conception.

Participants/materials, setting, methods
After obtaining informed consent women with at least two previous unexplained RIF, who were candidates for frozen-thawed embryo transfer were treated with intrauterine infusion of 0.8 ml of Implansera was infused into uterine cavity in addition to standard HRT protocols 2 days before ET. 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
Among 21 women, 10 achieved pregnancy (47.6%), while 11 did not conceive (52.4%). Clinical outcomes varied: 1 woman (4.8%) experienced chemical pregnancy, 3 (14.3%) miscarried before 6-12 weeks, 3 (14.3%) delivered healthy full-term babies, and 3 (14.3%) are in the 24th week of uneventful gestation accounts for 28.6% cumulative successful pregnancy outcomes. Implansera treatment yielded no reported adverse effects.Implansera, prepared through a patented proprietary process, standardized to contain 6-9 times higher growth factors than peripheral blood, particularly implantation-friendly and anti-inflammatory cytokines, addresses the crucial angiogenic and anti-inflammatory requirements for successful implantation. Tailored for the cyclical demands of endometrial proliferation, secretion, and implantation phases, it efficiently restores impaired uterine environments.Beyond efficacy, Implansera’s safety, reproducibility, and effectiveness in emulating natural tissue repair and regeneration processes are noteworthy. Studies underscore the significance of creating an environment conducive to successful implantation, and Implansera’s composition aligns with these requirements. Its capacity to mimic natural processes positions it as a promising solution, offering a comprehensive approach to enhancing endometrial receptivity, thus optimizing conditions for successful pregnancies.

Limitations, reasons for caution
This self-controlled prospective study, albeit with small sample size and lacking randomized control group, aligns with published data in demonstrating Implansera’s benefits. Proposing larger studies, particularly with unexplained RIF, to establish Implansera as routine IVF adjuvant. Further investigations aim to identify active molecules influencing implantation and suggest targeted recommendations.

Wider implications of the findings
Implansera improved implantation, pregnancy, and live birth rates (LBR) in unexplained RIF patients which indicates clearly endometrial thickness and receptivity improvement and motivated us to plan randomized controlled studies to confirm the results and provide opportunity for women with unexplained RIF to conceive and deliver in lesser number of cycles.

Trial registration number
Not applicable