Study of Personalized Follitropin Delta Dosing with a Long GnRH Agonist Protocol in Women Undergoing IVF or ICSI

What this Trial Is About

Researchers are evaluating a personalized dosing regimen of a hormone called Follitropin delta in women undergoing controlled ovarian stimulation for in vitro fertilization IVF or intracytoplasmic sperm injection ICSI using a long GnRH agonist protocol. This observational study, called REWAG, aims to see how well this individualized hormone dosing works in routine fertility treatment settings and whether it helps balance ovarian stimulation to reduce risks while achieving good outcomes. Women in the study receive Follitropin delta, a recombinant follicle-stimulating hormone, with doses adjusted based on their weight and blood levels of anti-Mllerian hormone AMH. The dosing follows standard clinical practice, with no experimental drugs or procedures given by the study. Participants are treated at fertility centers across Germany, and all decisions about treatment remain with their doctors. Participants will be involved only in routine visits and medical documentation, with no extra procedures required for the study. Researchers will collect data on the number of eggs retrieved, pregnancy rates, treatment cancellations, and any side effects, including ovarian hyperstimulation syndrome from egg retrieval to week 20 of pregnancy. They will also analyze how patient characteristics affect treatment results. Personal data will be protected under strict privacy rules. The study plans to include about 350 women aged 18 to 44 years.

Follitropin Delta in Long GnRH-agonist Protocol