Status:
RECRUITING
Follitropin Delta in Long GnRH-agonist Protocol
Lead Sponsor:
Prof. Dr. med. M.Sc. Georg Griesinger
Collaborating Sponsors:
University Hopsital Schleswig Holstein Campus Lübeck
Conditions:
Infertility (IVF Patients)
Infertility
Eligibility:
FEMALE
18-44 years
Brief 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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 9 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06995261
Start Date
July 9 2025
End Date
December 1 2027
Last Update
July 29 2025
Active Locations (4)
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1
Department of Obstetrics, Gynecology and Reproductive Endocrinology (UniKiD), Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40225
2
Center for Reproductive Medicine, IVF SAAR
Saarbrücken, Saarland, Germany, 66113
3
Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
4
Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538