Universitair Ziekenhuis Brussel
Brussels, Belgium
NCT Number: NCT03066349
Patients who undergo in vitro fertilization with or without intracytoplasmic sperm injection (IVF / ICSI) often experience an impact on their quality of life and emotional maladjustment to treatment and outcome. Multiple contributors to this negative impact have been identified, including interference with professional activities, expenses related to fertility treatment and hormonal side effects. In-vitro maturation (IVM) of human oocytes obtained from minimally stimulated or unstimulated ovaries offers a more "patient friendly" treatment option than the conventional ovarian stimulation protocols for Assisted Reproductive Technology (ART) treatment. Historically, IVM has been offered to women with increased ovarian response (so-called "high responders"), typically women with polycystic ovaries (PCO/PCOS), who are at increased risk for ovarian hyperstimulation syndrome (OHSS) if conventional ART protocols are used. IVM treatment programs are characterised by a minimal administration of fertility hormones, are less disruptive to patients' daily life through a reduced need for hormonal and ultrasound monitoring, avoid a range of minor and major complications because of the reduced hormonal burden of this procedure, and aim to reduce the total cost for of infertility treatment.
To facilitate the application of IVM as a treatment that can potentially improve the overall patient experience, a study comparing the psychological impact of a conventional ovarian stimulation protocol versus an IVM protocol will be conducted; furthermore, a study investigating the differences in quality of life between the two subgroups will also be performed.
Socio-demographic data, medical characteristics and the following questionnaires will be collected: Specific questions for patients with fertility problems (FertiQol); Hospital Anxiety and Depression Scale (HAD) and an instrument to measure side effects designed by the research group. The study group (IVF patients and IVM patients) will be evaluated at three predefined time points: at intake, after oocyte collection and when the outcome after the first embryo transfer is known.
Descriptive analysis, intergroup comparisons and explanatory/predictive model of the dependent variables (quality of life, emotional adjustment) will be performed.
Looking for future studies?
Notify Me18 year–36 year
Female
Observational
Brussels, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FertiQoL and HADS (Hospital Anxiety and Depression Scale) questionnaires
Time frame: 3 months
Assessment of the influences of fertility problems in diverse life areas, for example, on general health, self-perceptions, emotions, partnership, family and social relationships, work life and future life plans.
Time frame: 3 months
Tool to determine the levels of anxiety and depression that a patient is experiencing
Universitair Ziekenhuis Brussel
Other
Conventional Ovarian Stimulation vs. in Vitro Oocyte Maturation (IVM) Followed by in Vitro Fertilisation (IVF): Differences in Patients' Emotional Adjustment and Quality of Life
Acronym: EMAQOLIVMIVF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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