ART - Assisted Reproductive Technology
Conditions
Interventions
Group 1: Adult female patient with an indication for in-vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI)
Sponsors
GEDEON RICHTER PHARMA GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Eligible patients must meet the following criteria: - Adult female patient with an indication for IVF/ICSI treatment - Planned first ART stimulation cycle - Planned to receive Bemfola® as monotherapy for ovarian stimulation - Signed Informed Patient Consent form (ICF)
Exclusion criteria
Exclusion criteria: Eligible patients must not meet the following criteria: - History of previous poor response to gonadotropins outside ART - Planned Fertility Protection (due to malignancies etc.) - Ovarian Random Start and Duo Stimulations - Serum AMH-Level < 1,0 ng/ml
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of typical characteristics of previously planned (elective) and unplanned freeze-all procedures after stimulation with Bemfola®, with a specific focus on non-elective freeze-all procedures as a response to the risk of ovarian hyperstimulation syndrome (OHSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of frequency, indications, burdens and results of the freeze-all procedure Assessment of the medicinal endometrial preparation (priming) when transferring cryopreserved embryos Obtaining data from the daily practice (real-world data) on further treatment parameters for fertilization, cryopreservation, embryo development, luteal phase support, as well as implantation and pregnancy rates Description of the tolerability profile of Bemfola®, including the incidence of Ovarian Hyperstimulation Syndrome (OHSS) and other adverse drug reactions (ADRs) | — |
Countries
Austria, Germany
Outcome results
None listed