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

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 44
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Department of Obstetrics, Gynecology and Reproductive Endocrinology (UniKiD), Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf
RECRUITING
Düsseldorf
Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Kiel
RECRUITING
Kiel
Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Lübeck
RECRUITING
Lübeck
Center for Reproductive Medicine, IVF SAAR
RECRUITING
Saarbrücken
Contact Information
Primary
Georg Griesinger, MD
georg.griesinger@uni-luebeck.de
+49 451 505 778 212
Backup
Lilit Kamalyan, MD, PhD
Lilit.Kamalyan@uksh.de
+49 451 505 778 212
Time Frame
Start Date: 2025-07-09
Estimated Completion Date: 2027-12
Participants
Target number of participants: 350
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: University Hopsital Schleswig Holstein Campus Lübeck
Leads: Prof. Dr. med. M.Sc. Georg Griesinger

This content was sourced from clinicaltrials.gov

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