Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
350 participants
OBSERVATIONAL
2025-07-09
2027-12-31
Brief Summary
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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 approximately 350 women who are undergoing routine IVF/ICSI treatment. No experimental drugs or procedures are involved. All treatment decisions remain the responsibility of the attending physicians and follow standard clinical practice. Data will be collected only from routine visits and medical documentation, with no additional interventions required for participation.
Researchers will analyze outcomes such as the number of eggs retrieved, pregnancy rates, treatment cancellations, and any side effects. The study will also look at whether certain patient characteristics can predict how well the treatment works or whether complications may arise.
Participation is voluntary. All personal data will be pseudonymized and handled according to strict data protection regulations (GDPR). Results will help to improve understanding of how personalized hormone dosing performs in real-life settings and may support more tailored and effective fertility treatments in the future.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Follitropin Delta in Long GnRH Agonist Protocol
This cohort includes women undergoing controlled ovarian stimulation for IVF or ICSI treatment using Follitropin delta administered in a long GnRH agonist protocol. The dosing is individualized based on AMH serum levels and body weight. Participants are treated according to routine clinical practice, and no study drug is provided. The study is non-interventional.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
44 Years
FEMALE
No
Sponsors
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University Hopsital Schleswig Holstein Campus Lübeck
OTHER
Prof. Dr. med. M.Sc. Georg Griesinger
OTHER
Responsible Party
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Prof. Dr. med. M.Sc. Georg Griesinger
Professor of Gynecological Endocrinology and Reproductive Medicine, Director, IVF Center, University of Lübeck / UKSH
Locations
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Department of Obstetrics, Gynecology and Reproductive Endocrinology (UniKiD), Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Center for Reproductive Medicine, IVF SAAR
Saarbrücken, Saarland, Germany
Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, Germany
Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Lobo R, Soerdal T, Ekerhovd E, Cohlen B, Porcu E, Schenk M, Shufaro Y, Smeenk J, Suerdieck MB, Pinton P, Pinborg A; BEYOND Investigators. BEYOND: a randomized controlled trial comparing efficacy and safety of individualized follitropin delta dosing in a GnRH agonist versus antagonist protocol during the first ovarian stimulation cycle. Hum Reprod. 2024 May 9;39(7):1481-94. doi: 10.1093/humrep/deae092. Online ahead of print.
Other Identifiers
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2025-123 EC Luebeck
Identifier Type: -
Identifier Source: org_study_id
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