Using Rekovelle (follitropin delta) with a long GnRH‑agonist protocol for IVF/ICSI
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
This study tries individualized dosing of follitropin delta (Rekovelle) based on weight and AMH for women undergoing IVF or ICSI with a long GnRH‑agonist protocol.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | University of Luebeck Academic / other |
| Locations | 4 sites (Düsseldorf, North Rhine-Westphalia and 3 other locations) |
| Trial ID | NCT06995261 on ClinicalTrials.gov |
What this trial studies
REWAG is a non-interventional, real-world observational study conducted at several fertility centers in Germany of roughly 350 women undergoing controlled ovarian stimulation with a long luteal GnRH‑agonist protocol. Women receive follitropin delta (Rekovelle) dosed individually according to body weight and AMH as specified in the product information and routine practice. Data collected include stimulation response, oocyte retrieval outcomes, and safety signals such as ovarian hyperstimulation syndrome (OHSS). The study documents how the individualized dosing algorithm performs in routine clinical practice rather than testing a new drug or experimental procedure.
Who should consider this trial
Good fit: Women aged 18–44 planning IVF/ICSI with a long luteal GnRH‑agonist protocol, using follitropin delta per the SmPC, and with a recent AMH between 0.3 and 4.9 ng/ml are the intended participants.
Not a fit: Women with AMH values below 0.3 ng/ml or above 4.9 ng/ml, those older than 44, or those using antagonist protocols, alternative stimulation regimens, or different ovulation triggers are unlikely to be helped by the dosing approach studied here.
Why it matters
Potential benefit: If successful, this approach could better tailor ovarian stimulation to reduce the risk of OHSS while maintaining good egg retrieval and treatment outcomes.
How similar studies have performed: Previous clinical trials and real‑world reports have supported individualized follitropin delta dosing for tailored ovarian stimulation, but published real‑world data specifically in long GnRH‑agonist protocols are more limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Düsseldorf, North Rhine-Westphalia and 3 other locations
- Department of Obstetrics, Gynecology and Reproductive Endocrinology (UniKiD), Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
- Center for Reproductive Medicine, IVF SAAR — Saarbrücken, Saarland, Germany (Recruiting)
- Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Kiel — Kiel, Schleswig-Holstein, Germany (Recruiting)
- Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Lübeck — Lübeck, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Study coordinator: Georg Griesinger, MD
- Email: georg.griesinger@uni-luebeck.de
- Phone: +49 451 505 778 212
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.