NCT06995261 (REWAG) is a clinical trial in Infertility (IVF Patients), sponsored by Prof. Dr. med. M.Sc. Georg Griesinger.

Who is sponsoring NCT06995261?

NCT06995261 is sponsored by Prof. Dr. med. M.Sc. Georg Griesinger.

What condition does NCT06995261 study?

NCT06995261 studies Infertility (IVF Patients), Infertility, Infertility Drugs.

Is NCT06995261 still recruiting?

NCT06995261 is currently recruiting now. Last updated 24 July 2025.

Last reviewed 2025-07-24 · How we verify

NCT06995261: REWAG

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Performance of an Individual Dosing Regimen of Follitropin Delta (Fd) in a GnRH Agonist Protocol for Controlled Ovarian Stimulation for IVF/ICSI in a Real-word Setting: a Non-interventional Cohort Study

Recruiting now Last updated 24 July 2025

What this trial tests

trial in Infertility (IVF Patients) in 350 participants. Currently enrolling.

Timeline

9 July 2025

Primary endpoint
1 April 2027

1 December 2027

Quick facts

Lead sponsor	Prof. Dr. med. M.Sc. Georg Griesinger
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	350
Start date	9 July 2025
Primary completion	1 April 2027
Estimated completion	1 December 2027
Sites	4 locations across Germany

Conditions studied

Infertility (IVF Patients) — all drugs for Infertility (IVF Patients) →
Infertility — all drugs for Infertility →
Infertility Drugs — all drugs for Infertility Drugs →

Sponsor

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

Who can join

Adults 18 to 44, female only, with Infertility (IVF Patients) or Infertility. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06995261 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Prof. Dr. med. M.Sc. Georg Griesinger
Last refreshed: 24 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06995261.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing