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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2023-04-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility, Female Polycystic Ovary Syndrome Psychological Stress Quality of Life

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with PCOS undergoing conventional ovarian stimulation

Questionnaires

Intervention Type OTHER

FertiQoL and HADS (Hospital Anxiety and Depression Scale) questionnaires

Patients with PCOS undergoing IVM

Questionnaires

Intervention Type OTHER

FertiQoL and HADS (Hospital Anxiety and Depression Scale) questionnaires

Interventions

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Questionnaires

FertiQoL and HADS (Hospital Anxiety and Depression Scale) questionnaires

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No