Clinical trial NCT06995261: Real-World Observational Study on the Use of Individualized Follitropin Delta Dosing for Controlled Ovarian Stimulation in Women Undergoing IVF Using a Long GnRH Agonist Protocol in Routine Clinical Practice
Official title: The Performance of an Individual Dosing Regimen of Follitropin Delta (Fd) in a GnRH Agonist Protocol for Controlled Ovarian Stimulation for IVF/ICSI in a Real-word Setting: a Non-interventional Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Infertility (IVF Patients)
Infertility
Infertility Drugs
Keywords: follitropin delta
Rekovelle
Long GnRH-agonist protocol
individualized ovarian stimulation
Dosing algorithm
FSH
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: University Hopsital Schleswig Holstein Campus Lübeck
First posted: 2025-05-29
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile women undergoing IVF oder ICSI. This study is intended to be conducted in non-vulnerable population. No vulnerable subjects will be enrolled in the study.

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Ovarian Hyperstimulation Syndrome (OHSS)
timeFrame: From oocyte pick-up to gestational week 20
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Department of Obstetrics, Gynecology and Reproductive Endocrinology (UniKiD), Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf
state: Nordrhein-Westfalen
city: Saarbrücken
country: Germany
facility: Center for Reproductive Medicine, IVF SAAR
state: Saarland
city: Kiel
country: Germany
facility: 3. Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Kiel
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Lübeck
state: Schleswig-Holstein
Study officials:
References:
citation: 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.