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Follitropin Delta in Long GnRH-agonist Protocol

Recruitingn/aAges 18 Years - 44 YearsFemaleProf. Dr. med. M.Sc. Georg Griesinger
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In plain words

What the trial is, and whether it could suit you

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 overstimulation (OHSS) while still achieving good treatment outcomes. The study will include approxim

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 LUMIPULSE G AMH (Fujirebio) * Most recent serum AMH value before start of stimulation older than 12 months * Serum AMH within 12 months prior to treatment AMH ≤ 0.3 ng/ml or ≥4.9 ng/ml measured within 12 months prior to treatment * Pre-treatment with a combined oral contraceptive "pill" consisting of ethinyl estradiol and a synthetic progestogen or a natural estradiol/progesterone * Anovulatory PCOS syndrome * Women with a contraindication for prescription of Fd treatment * Women undergoing ovarian stimulation for fertility preservation
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What it tests

  • Not listed
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Where

4 sites
Department of Obstetrics, Gynecology and Reproductive Endocrinology (UniKiD), Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf
Düsseldorf, Germany
Center for Reproductive Medicine, IVF SAAR
Saarbrücken, Germany
Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Kiel
Kiel, Germany
Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Lübeck
Lübeck, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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