NCT03066349: EMAQOLIVMIVF

IVM Versus IVF: Differences in Patients' Emotional Adjustment and Quality of Life

Completed Last updated 7 April 2023

What this trial tests

trial testing Questionnaires in Infertility, Female in 149 participants. Completed in 6 April 2023.

Timeline

1 August 2017

Primary endpoint
6 April 2023

6 April 2023

Quick facts

Lead sponsor	Universitair Ziekenhuis Brussel
Status	Completed
Study type	OBSERVATIONAL
Enrollment	149
Start date	1 August 2017
Primary completion	6 April 2023
Estimated completion	6 April 2023
Sites	1 location across Belgium

Drugs / interventions tested

• Questionnaires

Conditions studied

• Infertility, Female — all drugs for Infertility, Female →
• Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
• Psychological Stress — all drugs for Psychological Stress →
• Quality of Life — all drugs for Quality of Life →

Sponsor

Universitair Ziekenhuis Brussel — full company profile →

Who can join

Adults 18 to 36, female only, with Infertility, Female or Polycystic Ovary Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. P-493 Sex and fertility education in the UK: an analysis of biology curricula and students’ experiences
   Maslowski K, Reiss M, Biswakarma R, Harper J. · · 2022