Follitropin Delta in Long GnRH-agonist Protocol
The REWAG study ("Real-world Evaluation of Women undergoing Agonist protocol with Follitropin delta") is a non-interventional observational study conducted across several fertility centers in Germany. The goal of this study is to evaluate how well a personalized dosing regimen of a hormone called Follitropin delta work
| Condition(s) | Infertility (IVF Patients), Infertility, Infertility Drugs |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The REWAG study ("Real-world Evaluation of Women undergoing Agonist protocol with Follitropin delta") is a non-interventional observational study conducted across several fertility centers in Germany. The goal of this study is to evaluate how well a personalized dosing regimen of a hormone called Follitropin delta works in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using a long GnRH agonist protocol. Follitropin delta is a recombinant follicle-stimulating hormone (rFSH) that allows for individualized dosing based on a woman's weight and a blood marker called anti-Müllerian hormone (AMH). This personalized approach may help to better balance the stimulation of the ovaries, aiming to reduce the risk of ove |
| Who can participate | Inclusion Criteria: * Age ≥18 to ≤ 44 years at enrolment * Planned stimulation in a long luteal GnRH agonist protocol with daily s.c. GnRH-agonist * Planned use of Fd for ovarian stimulation as per SmPC * Serum AMH ≥0.3 ng/ml to ≤4.9 ng/ml measured within12 months prior to treatment * Most recent serum AMH value before start of stimulation not older than 12 months * Planned IVF or ICSI treatment in a first or second attempt with ejaculated or cryopreserved male germ cells, autologous or heterologous, with or without planned genetic testing of the oocytes or embryos * Planned triggering of final oocyte maturation with hCG * Willingness and consent to participate Exclusion Criteria: * Serum AMH value not determined in ELECSYS AMH Plus Immunoassay, ACCESS AMH Advanced (Beckham Coulter) or LUM |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Lead sponsor | Prof. Dr. med. M.Sc. Georg Griesinger |
| Locations | Düsseldorf, North Rhine-Westphalia, Germany; Saarbrücken, Saarland, Germany; Kiel, Schleswig-Holstein, Germany; Lübeck, Schleswig-Holstein, Germany |
| Start date | 2025-07-09 |
| NCT ID | NCT06995261 |
| Official listing | https://clinicaltrials.gov/study/NCT06995261 |