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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 4
- 主要终点
- Ovarian Hyperstimulation Syndrome (OHSS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Ovarian Hyperstimulation Syndrome (OHSS)
时间窗: From oocyte pick-up to gestational week 20
Ovarian Hyperstimulation Syndrome (OHSS) of any grade and any onset by Golan classification
次要结局
未报告次要终点
研究者
Prof. Dr. med. M.Sc. Georg Griesinger
Professor of Gynecological Endocrinology and Reproductive Medicine, Director, IVF Center, University of Lübeck / UKSH
University of Luebeck