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Real-world Evidence on Follitropin Delta Individual Dosing

Recruitingn/aAges 18 Years - 44 YearsAllUniversity of Luebeck
NCT05173597 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

As part of the in vitro fertilisation treatment, ovarian stimulation is routinely performed. For this purpose, FSH preparations are used. Follitropin delta is a FSH preparation that is approved for a wide range of applications and is dosed individually according to body weight and serum anti-Müllerian hormone (AMH). Body weight is used to estimate the distribution volume of the glycoprotein FD in the patient and is thus a proxy of exposure. The AMH is used to estimate the ovarian reserve and thus the number of follicles in the ovaries that can be recruited by Follitropin delta stimulation. An algorithm is used for individual dosing. The aim of individual dosing is to reduce the probability of an under or overreaction of the ovaries to FSH therapy. In contrast to phase III registration studies, patients with severe overweight and underweight, as well as very high and very low AMH values

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 to ≤ 44 years at enrolment * Planned stimulation in a fixed or flexible GnRH antagonist protocol * Planned use of follitropin delta for ovarian stimulation as per SmPC * Planned IVF or ICSI treatment with ejaculated or cryopreserved male germ cells, autologous or heterologous, with or without planned genetic testing of the oocytes or embryos * Planned preservation of MII oocytes (fertility preservation) * Planned triggering of final oocyte maturation with hCG or a GnRH agonist * Willingness and consent to participate Exclusion Criteria: * Serum AMH within 12 months prior to treatment ≤0.3 ng/ml * Most recent serum AMH value before start of stimulation older than 12 months * Serum AMH value not determined in Roche Elecsys immunoassays * Pre-treatment with a combined oral contraceptive "pill" consisting of ethinyl estradiol and a synthetic progestogen
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What it tests

  • Follitropin delta
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Where

1 site
University of Luebeck
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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