Follitropin Delta in Long GnRH-agonist Protocol

NCT06995261 · tracked via the Priya Life Science Germany tracker

Sponsor

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

Phase

Observational

Started

2025-07-09

Last updated

2025-07-29

Condition(s) studied

Infertility (IVF Patients)InfertilityInfertility Drugs

Study 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

Sex

FEMALE

Min age

18 Years

Max age

44 Years

Healthy volunteers

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 outcome measure(s)

Ovarian Hyperstimulation Syndrome (OHSS) — From oocyte pick-up to gestational week 20
Ovarian Hyperstimulation Syndrome (OHSS) of any grade and any onset by Golan classification

Trial sites (4)

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

Other trials for the same condition

Real-world Evidence on Follitropin Delta Individual Dosing Recruiting

Clinical Cohort Study on the Endocrinology and Vaginal/Endometrial Microbiome of the Luteal Phase in Assisted Reproduction Recruiting

Impact of a Predetermined Day 5 ET vs. a Predetermined Day 6 ET on Clinical Pregnancy Rate After ICSI Treatment Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06995261 on ClinicalTrials.gov ↗ ← All trials in Germany