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

NCT03066349 | Completed

• 1 other identifier: EMAQOL_2017
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hospital Anxiety and Depression Scale

  3 months

Study Arms (2)

Patients with PCOS undergoing conventional ovarian stimulation

Other: Questionnaires

Patients with PCOS undergoing IVM

Other: Questionnaires

Interventions

Questionnaires OTHER

FertiQoL and HADS (Hospital Anxiety and Depression Scale) questionnaires

Patients with PCOS undergoing IVM; Patients with PCOS undergoing conventional ovarian stimulation

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female infertility patients between 18 and 36 years.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• University of the Basque Country (UPV/EHU): collaborator

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

MeSH Terms

Conditions

Infertility, Female; Polycystic Ovary Syndrome; Stress, Psychological

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Michel De Vos

  UZ Brussel - VUB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kliniekhoofd en Klinisch Professor

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: August 1, 2017
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)