Individual dosing of Follitropin Delta for ovarian stimulation in infertility treatment
Official title: The Performance of an Individual Dosing Regimen of Follitropin Delta for Controlled Ovarian Stimulation for IVF in a Real-word Setting: a Non-interventional Observational Study
Run by University of Luebeck · NCT05173597 · Data updated 2026-11-12
This study is testing if adjusting the dose of a hormone called Follitropin Delta based on a woman's weight and hormone levels can help improve ovarian stimulation for women undergoing IVF or ICSI.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 44 Years |
| Sex | All |
| Enrollment | 850 (estimated) |
| Sponsor | University of Luebeck Academic / other |
| Locations | 1 site (Lübeck, Schleswig-Holstein) |
| Status | Recruiting |
| Started | December 8, 2021 |
| Main results expected | March 2026 |
| Study ends | March 2026 |
| Registry record updated | March 30, 2025 |
| Trial ID | NCT05173597 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 to 44 years who are planning to undergo ovarian stimulation with Follitropin Delta as part of their fertility treatment.
✕Probably not a fit
Patients with very low serum AMH levels (≤0.3 ng/ml) or those who have not had their AMH levels tested within the last 12 months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on the individual dosing of Follitropin Delta, a follicle-stimulating hormone (FSH) preparation, for ovarian stimulation in women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The dosing is tailored based on the patient's body weight and serum anti-Müllerian hormone (AMH) levels to optimize ovarian response and minimize risks. The study includes a diverse patient population, including those with varying body weights and AMH levels, to reflect real-world scenarios. The goal is to improve the effectiveness of ovarian stimulation while reducing the likelihood of complications such as ovarian hyperstimulation syndrome.
Why it matters
Potential benefit: If successful, this approach could enhance the success rates of IVF and ICSI treatments for patients struggling with infertility.
How similar studies have gone: While individual dosing approaches have been explored, this specific observational study aims to gather real-world evidence, making it a novel contribution to the field.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University of Luebeck
Lübeck, Schleswig-Holstein, Germany Recruiting
Study contacts
- Study coordinator: Georg Griesinger, MD
- Email: georg.griesinger@uni-luebeck.de
- Phone: +49 451-500-41950
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.