Using Rekovelle (follitropin delta) with a long GnRH‑agonist protocol for IVF/ICSI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

REWAG is a non-interventional, real-world observational study conducted at several fertility centers in Germany of roughly 350 women undergoing controlled ovarian stimulation with a long luteal GnRH‑agonist protocol. Women receive follitropin delta (Rekovelle) dosed individually according to body weight and AMH as specified in the product information and routine practice. Data collected include stimulation response, oocyte retrieval outcomes, and safety signals such as ovarian hyperstimulation syndrome (OHSS). The study documents how the individualized dosing algorithm performs in routine clinical practice rather than testing a new drug or experimental procedure.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Georg Griesinger, MD
• Email: georg.griesinger@uni-luebeck.de
• Phone: +49 451 505 778 212

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.