Follitropin Delta in Long GnRH-agonist Protocol

Sponsor
Prof. Dr. med. M.Sc. Georg Griesinger
Study ID
NCT06995261
Status
Recruiting
Apply to this trial

Conditions

  • Infertility
  • Infertility (IVF Patients)
  • Infertility Drugs

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
May 29, 2025
Start date
Jul 9, 2025
Status verified
Jul 2025
Primary completion
Apr 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
350 participants (estimated)

Arms

  • Arm: Follitropin Delta in Long GnRH Agonist Protocol
    This cohort includes women undergoing controlled ovarian stimulation for IVF or ICSI treatment using Follitropin delta administered in a long GnRH agonist protocol. The dosing is individualized based on AMH serum levels and body weight. Participants are treated according to routine clinical practice, and no study drug is provided. The study is non-interventional.

Primary Outcome Measure

Ovarian Hyperstimulation Syndrome (OHSS) [ Time Frame: From oocyte pick-up to gestational week 20 ]

Central Contacts

Related Studies