Follitropin Delta in Long GnRH-agonist Protocol

Recruiting now

Conditions studied: Infertility (IVF Patients), Infertility, Infertility Drugs

In brief

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.

Key facts

Study ID: NCT06995261
Run by: Prof. Dr. med. M.Sc. Georg Griesinger
People needed: 350
Starts: 2025-07-09
Expected to finish: 2027-12-01
Last updated by the study team: 2025-07-29

Who can join

Age: 18 and older, up to 44. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

Department of Obstetrics, Gynecology and Reproductive Endocrinology (UniKiD), Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany (enrolling)
Center for Reproductive Medicine, IVF SAAR — Saarbrücken, Saarland, Germany (enrolling)
Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Kiel — Kiel, Schleswig-Holstein, Germany (enrolling)
Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Lübeck — Lübeck, Schleswig-Holstein, Germany (enrolling)

Full record on ClinicalTrials.gov

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