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

Quality of Life Clinical Trial

— EMAQOLIVMIVF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066349
• Other study ID #: EMAQOL_2017
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: April 6, 2023

Study information

• Verified date: April 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: April 6, 2023
• Est. primary completion date: April 6, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Polycystic Ovary Syndrome
• Psychological Stress
• Quality of Life
• Stress, Psychological

Intervention

Other:
• Questionnaires
FertiQoL and HADS (Hospital Anxiety and Depression Scale) questionnaires

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussel

Sponsors (2)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	University of the Basque Country (UPV/EHU)

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospital Anxiety and Depression Scale	Tool to determine the levels of anxiety and depression that a patient is experiencing	3 months