Clinical Research Directory

rFSH vs rFSH+rLH in Dydrogesterone-Based Progestin Protocol: A Prospective Study

This study aims to compare two commonly used hormone treatments for women undergoing IVF. All participants will receive a stimulation protocol that includes dydrogesterone, a medication used to safely control natural hormone surges during treatment. The study will observe women who are treated either with recombinant FSH alone or with a combination of recombinant FSH and recombinant LH-both routinely used options in our clinic. Investigators will prospectively monitor how these treatments affect the growth of ovarian follicles, the number of mature eggs collected, the quality of developing embryos, and early pregnancy outcomes. No additional procedures or medications will be required beyond standard IVF care. The goal is to better understand whether adding recombinant LH provides any measurable benefit in dydrogesterone-based PPOS cycles.

To Investigate if the Harvester® Improves Sperm Motility and Blastocyst Utilization (the Percent of Fertilized Eggs That Develop to the Point That They Are Able to be Transferred) in IVF Cycles.

The goal of this prospective, multicenter randomized controlled clinical trial is to evaluate whether the SwimCount Harvester microfluidic sperm preparation device can achieve equivalent or superior clinical outcomes compared to standard sperm preparation methods (density gradient centrifugation and swim-up) in couples undergoing in vitro fertilization (IVF) with preimplantation genetic testing for aneuploidy (PGT-A). The study population includes adult couples (female partner age 21-45 years; male partner age ≥21 years) undergoing IVF with PGT-A who meet minimum semen eligibility criteria on the day of oocyte retrieval: pre-processing volume ≥1mL, sperm concentration ≥1 million/mL, and progressive motility ≥10%. A total of 1,600 patients will be randomized 1:1 across 15-25 high-volume IVF centers to receive either Harvester or the site's predominant standard-of-care sperm preparation method. Patients with surgical sperm retrieval requirements or those currently using SwimCount Harvester as standard of care are excluded. The main questions it aims to answer are: Does the SwimCount Harvester demonstrate noninferiority to standard sperm preparation methods on blastocyst utilization rate? The primary endpoint is blastocyst utilization rate, calculated as the number of usable blastocysts (operationalized as biopsied blastocysts per clinic standard operating procedures) divided by the number of normally fertilized oocytes (2PN) at the patient level. Noninferiority will be concluded if the lower bound of the two-sided 95% confidence interval for the risk difference (Harvester minus standard of care) is greater than -2.0 percentage points, using a site-stratified Mantel-Haenszel analysis. If noninferiority is met, superiority may be reported as supportive evidence when the lower confidence bound exceeds zero. Does the SwimCount Harvester demonstrate noninferiority to standard sperm preparation methods on the probability of obtaining at least one euploid embryo per retrieval? The key secondary endpoint assesses whether patients have at least one euploid embryo (yes/no) based on PGT-A results from a single blinded reference laboratory (NOVA Genomics). This will be analyzed as a site-stratified Mantel-Haenszel risk difference with a two-sided 95% confidence interval, with an optional noninferiority margin of -2.5 percentage points presented as supportive evidence. Additional supportive and exploratory questions include: * How does progressive motility change from pre- to post-preparation with each method? Progressive motility will be summarized descriptively pre- and post-preparation as a supportive laboratory measure without hypothesis testing. * Do outcomes differ in clinically important subgroups? Pre-specified exploratory analyses will examine advanced maternal age (≥40 years) and severe oligospermia (\<5 million/mL), populations that may derive differential benefit from advanced sperm selection. * What are the practical implementation considerations? An independent protocol complexity analysis will assess procedural steps, equipment requirements, and standardization benefits by comparing site standard-of-care protocols to the Harvester Instructions for Use. The study addresses a critical evidence gap by providing multicenter, adequately powered data on whether advanced microfluidic sperm preparation translates into meaningful clinical improvements in IVF success metrics.

Follicular Fluid microRNAs in Ovarian Aging and Reproduction

The purpose of this study is to investigate the role of exosomal microRNAs (miRNAs) in follicular fluid (FF) as biomarkers of ovarian aging and predictors of in vitro fertilization (IVF) outcomes. The goal is to identify noninvasive molecular markers that correlate with oocyte quality and reproductive potential, particularly in women of advanced maternal age.