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

Conventional Ovarian Stimulation vs. in Vitro Oocyte Maturation (IVM) Followed by in Vitro Fertilisation (IVF): Differences in Patients' Emotional Adjustment and Quality of Life

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Polycystic Ovary Syndrome; Infertility, Female; Psychological Stress
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Actual): 149

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium
    • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female infertility patients between 18 and 36 years.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with PCOS undergoing conventional ovarian stimulation	Other: Questionnaires; FertiQoL and HADS (Hospital Anxiety and Depression Scale) questionnaires
Patients with PCOS undergoing IVM	Other: Questionnaires; FertiQoL and HADS (Hospital Anxiety and Depression Scale) questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FertiQol score	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale	Tool to determine the levels of anxiety and depression that a patient is experiencing	3 months

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Collaborators: University of the Basque Country (UPV/EHU)
• Investigators: Principal Investigator: Michel De Vos, UZ Brussel - VUB

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): April 6, 2023
• Study Completion (Actual): April 6, 2023

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Infertility; Stress, Psychological; Infertility, Female
• Other Study ID Numbers: EMAQOL_2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO