Real-World Observational Study on the Use of Individualized Follitropin Delta Dosing for Controlled Ovarian Stimulation in Women Undergoing IVF Using a Long GnRH Agonist Protocol in Routine Clinical Practice

Launched by PROF. DR. MED. M.SC. GEORG GRIESINGER · May 28, 2025

Keywords

ClinConnect Summary

The REWAG study is a research project that looks at how personalized dosing of a hormone called Follitropin delta can help women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). This study is being conducted in several fertility clinics in Germany and aims to see if tailoring the hormone dose to a woman’s weight and a specific blood marker (anti-Müllerian hormone or AMH) can improve the treatment outcomes while also reducing the risk of complications like ovarian overstimulation. About 350 women aged between 18 and 44 who are planning to start IVF or ICSI treatment will be included in this study.

If you participate, you will not be asked to undergo any new treatments; everything will follow standard procedures at your clinic. Researchers will gather information from your routine visits to see how many eggs are retrieved, the success of pregnancies, and any side effects experienced. Your personal information will be kept private, and participation is completely voluntary. This study hopes to improve our understanding of how personalized hormone treatment works in real-life situations, potentially leading to better fertility treatments in the future.

Gender

FEMALE

Eligibility 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