Follitropin Delta in Long GnRH-agonist Protocol

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.

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Key information

Conditions

Infertility (IVF Patients) Genital Diseases Infertility Infertility Drugs Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics, Gynecology and Reproductive Endocrinology (UniKiD), Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, North Rhine-Westphalia, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Ovarian Hyperstimulation Syndrome (OHSS)

Time frame: From oocyte pick-up to gestational week 20

Ovarian Hyperstimulation Syndrome (OHSS) of any grade and any onset by Golan classification

Study contacts

Contact information is provided by the study sponsor or research team.

Georg Griesinger, MD

CONTACT

[email protected]

+49 451 505 778 212

Lilit Kamalyan, MD, PhD

CONTACT

[email protected]

+49 451 505 778 212

Sponsors and collaborators

Lead sponsor

Prof. Dr. med. M.Sc. Georg Griesinger

Other

Collaborators

University Hopsital Schleswig Holstein Campus Lübeck

Registry information

Official study 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

Acronym: REWAG

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: May 29, 2025
Registry last updated: Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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