Infertility, FemaleEMAQOLIVMIVFNCT03066349
IVM Versus IVF: Differences in Patients' Emotional Adjustment and Quality of Life
An observational study of Infertility, Female and Polycystic Ovary Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Infertility, Female, Polycystic Ovary Syndrome, Psychological Stress
- What is being tested?
- Questionnaires
- How many people
- 149 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2017to 6 Apr 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- No healthy volunteers
- Adult
Study population: Female infertility patients between 18 and 36 years.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Being tested
- Questionnaires
- Medical subject headings
- Infertility, Female, Polycystic Ovary Syndrome, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
FertiQoL and HADS (Hospital Anxiety and Depression Scale) questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patients with PCOS undergoing conventional ovarian stimulation | Not described Receives: Other: Questionnaires | |
| Patients with PCOS undergoing IVM | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Hospital Anxiety and Depression Scale
Tool to determine the levels of anxiety and depression that a patient is experiencing
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start1 Aug 2017
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Basque Country (UPV/EHU)
- Responsible party
- Principal investigator, Michel De Vos, Universitair Ziekenhuis Brussel
- Investigators
- Michel De Vos, Principal investigator, UZ Brussel - VUB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066349
- Sponsor's protocol ID
- EMAQOL_2017
- Acronym
- EMAQOLIVMIVF
- Status last verified
- Apr 2023
- First submitted
- 23 Feb 2017
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03066349
- Acronym / sponsor ID
- EMAQOLIVMIVF / EMAQOL_2017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- University of the Basque Country (UPV/EHU)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with PCOS undergoing conventional ovarian stimulation | – | Other: Questionnaires |
| Patients with PCOS undergoing IVM | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female infertility patients between 18 and 36 years.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesFertiQoL and HADS (Hospital Anxiety and Depression Scale) questionnaires | Other | Patients with PCOS undergoing IVM, Patients with PCOS undergoing conventional ovarian stimulation |
Primary outcome
FertiQol score
Time frame: 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.
1 secondary outcome
Hospital Anxiety and Depression Scale
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel De Vos principal investigator
UZ Brussel - VUB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Polycystic Ovary Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FertiQol score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.