A multicenter randomized clinical trial with a novel decision support tool to improve IVF success

Graphical Abstract Abstract A small multi-center trial indicated that using a clinical decision support tool, Opt-IVF, to guide follicular-stimulating hormone (FSH) dosing during superovulation increased the number of high-quality embryos in non-PCOS patients treated with an antagonist protocol. This clinical trial aims to study whether Opt-IVF improves clinical pregnancy rates across all patient types and protocols without any exceptions. 402 women aged 25–45 undergoing in vitro fertilization (IVF) were enrolled in the trial. Half (201 women) were randomly assigned to the intervention group (Opt-IVF) to guide FSH dosing and determine the antagonist and trigger days. The other half was assigned to the control group (conventional treatment). The participants in the intervention group required significantly lower cumulative FSH doses during their controlled ovarian stimulation cycles. This group also had a higher number of M2 oocytes retrieved compared to the control group. Furthermore, the intervention group produced a significantly higher number of embryos and good-quality blastocysts, leading to increased pregnancy rates compared to the control group. We conclude that using the Opt-IVF clinical decision support tool led to numerous benefits, such as reducing the need for ultrasound examinations after day 5, lowering the required FSH dosage, and achieving a higher number of high-quality blastocysts and increased pregnancy rates. Thus, Opt-IVF offers a personalized, optimized, and simplified approach to superovulation. Lay summary IVF involves four main steps: stimulating the ovaries to produce multiple eggs (superovulation), retrieving the eggs, fertilizing them in a lab, and transferring the resulting embryos into the uterus. Despite being available worldwide, IVF remains costly in both wealthy and low-income countries. The high expenses are driven by expensive medications, infrastructure costs, extensive testing, and labor costs for healthcare professionals. Of the four steps, superovulation is the most expensive due to the need for frequent monitoring through ultrasounds and blood tests. A woman’s body normally releases just one monthly egg. But for IVF to work better, doctors give the woman daily hormones to help her body grow and release many eggs at once. This is superovulation. This stage is an important stage in IVF and influences the outcomes of the IVF to a large extent. Physicians determine the daily dosage of hormones based on general guidelines, observational data, and their clinical experience, but this dosage is not tailored for each individual, which can sometimes lead to overstimulation. The cost of drugs and testing makes this stage particularly expensive. To address these challenges, we developed a decision support tool called Opt-IVF, designed to provide a personalized and optimized dosage profile for each patient. The results of the trial show that Opt-IVF tailors the dosage to the individual, reduces the need for testing, and improves outcomes for patients. Trial registration ClinicalTrials.gov (ID – NCT05981898). Date of registration July 31 15, 2023. Date of enrollment for the first subject: September 15, 2023.