Ignite Creation Date:
2025-12-18 @ 9:08 AM
Ignite Modification Date:
2025-12-23 @ 10:01 PM
Study NCT ID:
NCT03066349
Status:
None
Last Update Posted:
2023-04-07 00:00:00
First Post:
2017-02-23 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IVM Versus IVF: Differences in Patients' Emotional Adjustment and Quality of Life
Sponsor:
None
Organization:
Study Overview
Official Title:
Conventional Ovarian Stimulation vs. in Vitro Oocyte Maturation (IVM) Followed by in Vitro Fertilisation (IVF): Differences in Patients' Emotional Adjustment and Quality of Life
Status:
None
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMAQOLIVMIVF
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: