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

Completed

• Conditions: Quality of Life; Polycystic Ovary Syndrome; Psychological Stress; Infertility, Female
• Interventions: Other: Questionnaires

• Registration Number: NCT03066349
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-28
• Study Start: 2017-08-01
• Status Verified: 2023-04
• Primary Completion: 2023-04-06
• Study Completion: 2023-04-06
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 149

Inclusion Criteria

• Heterosexual or homosexual women enrolled to undergo ART treatment
• Patients with polycystic ovarian morphology (12 or more small follicles observed during a baseline pelvic ultrasound scan) or polycystic ovary syndrome (PCOS) (Rotterdam criteria, 2003)

Exclusion Criteria

• Medical contra-indication for pregnancy
• High (>grade 2) grade endometriosis
• Patients who have previously undergone ART treatment
• Patients who require ART with PGD
• In vitro fertilisation with sperm retrieved through testicular biopsy
• Singles without a partner
• Couples who because of the language barrier (poor knowledge of Dutch, French or English) cannot reliably fill out the questionnaire.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PCOS undergoing conventional ovarian stimulation	Questionnaires	-
Patients with PCOS undergoing IVM	Questionnaires	-

Primary Outcome Measures

Name	Time	Method
FertiQol score	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.

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	3 months	Tool to determine the levels of anxiety and depression that a patient is experiencing

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussel, Belgium