Actively Recruiting

Age: 18Years - 44Years
FEMALE
ID06995261

The Performance of an Individual Dosing Regimen of Follitropin Delta in a GnRH Agonist Protocol for Controlled Ovarian Stimulation for IVF/ICSI in a Real-world Setting

Led by Prof. Dr. med. M.Sc. Georg Griesinger · Updated on 2025-07-29

350

Participants Needed

4

Research Sites

34 weeks

Total Duration

On this page

Sponsors

P

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

Lead Sponsor

U

University Hopsital Schleswig Holstein Campus Lübeck

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a personalized dosing regimen of a hormone called Follitropin delta in women undergoing controlled ovarian stimulation for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using a long GnRH agonist protocol. This observational study, called REWAG, aims to see how well this individualized hormone dosing works in routine fertility treatment settings and whether it helps balance ovarian stimulation to reduce risks while achieving good outcomes. Women in the study receive Follitropin delta, a recombinant follicle-stimulating hormone, with doses adjusted based on their weight and blood levels of anti-Müllerian hormone (AMH). The dosing follows standard clinical practice, with no experimental drugs or procedures given by the study. Participants are treated at fertility centers across Germany, and all decisions about treatment remain with their doctors. Participants will be involved only in routine visits and medical documentation, with no extra procedures required for the study. Researchers will collect data on the number of eggs retrieved, pregnancy rates, treatment cancellations, and any side effects, including ovarian hyperstimulation syndrome from egg retrieval to week 20 of pregnancy. They will also analyze how patient characteristics affect treatment results. Personal data will be protected under strict privacy rules. The study plans to include about 350 women aged 18 to 44 years.

CONDITIONS

Brief Title

Follitropin Delta in Long GnRH-agonist Protocol

Who Can Participate

Age: 18Years - 44Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to 44 years at enrollment
  • Planned controlled ovarian stimulation using a long luteal GnRH agonist protocol with daily subcutaneous GnRH agonist
  • Planned use of Follitropin delta for ovarian stimulation according to prescribing information
  • Serum AMH level between 0.3 ng/ml and 4.9 ng/ml measured within 12 months before treatment
  • Most recent AMH measurement not older than 12 months before stimulation start
  • Planned IVF or ICSI treatment in first or second attempt with ejaculated or cryopreserved male germ cells, autologous or heterologous, with or without genetic testing
  • Planned triggering of final oocyte maturation with hCG
  • Willingness and consent to participate in the study
Not Eligible

You will not qualify if you...

  • Serum AMH level not measured by ELECSYS AMH Plus Immunoassay, ACCESS AMH Advanced, or LUMIPULSE G AMH assays
  • Most recent AMH value older than 12 months before stimulation start
  • Serum AMH level outside 0.3 to 4.9 ng/ml range within 12 months before treatment
  • Pre-treatment with combined oral contraceptive pill containing ethinyl estradiol and progestogen or natural estradiol/progesterone
  • Diagnosis of anovulatory polycystic ovary syndrome (PCOS)
  • Contraindications to Follitropin delta treatment
  • Undergoing ovarian stimulation for fertility preservation rather than IVF/ICSI treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - From ovarian stimulation start until gestational week 20

Participants who undergo routine care for controlled ovarian stimulation with Follitropin delta in a long GnRH agonist protocol are observed. Measurements are collected before, during, and after ovarian stimulation according to routine clinical practice.

Visits according to routine clinical practice

Trial Site Locations

Total: 4 locations

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

Actively Recruiting

2

Center for Reproductive Medicine, IVF SAAR

Saarbrücken, Saarland, Germany, 66113

Actively Recruiting

3

Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, Germany, 24105

Actively Recruiting

4

Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Lübeck

Lübeck, Schleswig-Holstein, Germany, 23538

Actively Recruiting

Loading map...

Research Team

G

Georg Griesinger, MD

L

Lilit Kamalyan, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

A Parallel-group Treatment, 2-arm Study to Compare the Effic...

Infertility

Actively Recruiting

10 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

BEYOND: a randomized controlled trial comparing efficacy and safety of individualized follitropin delta dosing in a GnRH agonist versus antagonist protocol during the first ovarian stimulation cycle.

Rita Lobo, Terje Soerdal, Erling Ekerhovd...

https://pubmed.ncbi.nlm.nih.gov/38723189