- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03717805
The Evaluation of a Preparatory Information Movie on Oocyte Aspiration (POAM-RCT)
The Evaluation of a Preparatory Information Movie on Oocyte Aspiration: a Randomized Controlled Trial
Study Overview
Detailed Description
Title: The evaluation of a preparatory information movie on oocyte aspiration: a Randomized Controlled Trial (POAM-RCT) Study purpose: To evaluate whether the preparatory information movie on oocyte aspiration (POAM) decreases the anxiety of ART-couples on the day of their first oocyte aspiration.
Primary outcome: The primary outcome is women's 'state anxiety', which will be assessed with the reliable 'State Trait Anxiety Inventory, state module (STAI-state)' questionnaire upon arrival at the fertility clinic on the day of the oocyte aspiration.
Secondary outcomes: Three secondary patient-reported outcomes will be assessed simultaneously with the primary outcome, upon arrival at the fertility clinic for oocyte aspiration.
First, men's state anxiety will assessed with the STAI-state questionnaire. Second and third, in both women and men, infertility-specific distress will be assessed.
The following two secondary clinical outcomes will be followed-up in all couples 12 weeks after the oocyte aspiration: clinical pregnancy with fetal heart beat and miscarriage in case of clinical pregnancy with fetal heart beat.
Other outcomes: As a follow-up the following will be extracted from the medical charts of participating couples twelve months after the oocyte aspiration: long-term clinical outcomes (i.e. live birth from the first fresh embryo transfer, clinical pregnancy with fetal heart beat from the frozen embryo transfers of 1st IVF-cycle and the 12-months cumulative clinical pregnancy rates) and long-term discontinuation parameters (i.e. censored by their medical doctor to discontinue, IVF-delay or number of untreated cycles within 12 months and IVF-discontinuation or whether or not start a 2nd IVF-cycle was started within 12 months).
Study design: Randomized controlled trial Sample size: 190 couples will be randomized to the intervention or control group Summary of eligibility criteria: Inclusion criteria: Couples treated with a 1st cycle of ART (IVF or ICSI; with or without PGD). Couples with a genetic indication for PGD can be included as they are an important patient group and are as likely as infertile patients to experience anxiety when they first come for oocyte retrieval.
Exclusion criterion: Couples going through a subsequent cycle of ART are not eligible as they are not treatment naïve, but already know, from their first cycle, what will happen on the day of oocyte aspiration.
Maximum duration of treatment of a subject: Each couple will participate from their ART-intake until the day of their first oocyte aspiration.
Couples will be asked for informed consent during their ART-intake (i.e. individual or group session with midwife; 1-3 months prior to oocyte aspiration) and will then be randomized to either the intervention group or the control group.
Participating couples of the intervention group will receive care as usual and will watch the preparatory information movie on oocyte aspiration (POAM) 1-3 days before their oocyte aspiration. Their gynecologist or midwife will empower them to watch the movie when they call them to plan the oocyte aspiration and will send them the secured link to the movie via email.
Participating couples of the control group will receive care as usual (as will participating couples of the intervention group) and will not get access to the preparatory information movie on oocyte aspiration (POAM).
When they arrive at the fertility clinic on the day of oocyte aspiration both partners of participating couples of the intervention and control group will be asked to fill out a questionnaire (5-10 minutes) before any clinical procedures are performed.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eline Dancet, PhD
- Phone Number: 0032479635711
- Email: eline.dancet@kuleuven.be
Study Contact Backup
- Name: Myriam Welkenhuysen, Msc
- Phone Number: 00316433544
- Email: myriam.welkenhuysen@uzleuven.be
Study Locations
-
-
Antwerpen
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Wilrijk, Antwerpen, Belgium, 2610
- Recruiting
- GZA Ziekenhuizen campus Sint-Augustinus
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Contact:
- Louise Dias
- Phone Number: 03/443.35.49
- Email: louise.dias@gza.be
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
(i) Heterosexual woman and her partner
(ii) Dutch speaking
(iii) Treated with a 1st cycle of IVF (IVF or ICSI; with or without PGD)
Exclusion Criteria:
(i) Having already experienced an IVF-cycle in the same of another clinic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Participating couples of the intervention group will receive care as usual and will watch the preparatory information movie on oocyte aspiration (POAM) 1-3 days before their oocyte aspiration.
Their gynecologist or midwife will empower them to watch the movie when they call them to plan the oocyte aspiration and will send them the secured link to the movie via email.
|
The new 5 minutes preparatory information movie on oocyte aspiration (POAM) details what couples can expect to happen on the day of oocyte aspiration.
More specifically, it describes the patient journey detailing which procedures will happen when and how, in which room, in the presence of their partner or not, and in the presence of which healthcare professionals.
|
No Intervention: Control group
Participating couples of the control group will receive care as usual (as will participating couples of the intervention group) and will not get access to the preparatory information movie on oocyte aspiration (POAM).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Women's state anxiety
Time Frame: Responses on one single assessment of state-anxiety on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
|
Women's anxiety will be assessed with the 'State Trait Anxiety Inventory, state module (STAI-state; score 20-80, the higher the more anxious)' questionnaire (Spielberger et al, 2015; www.mingarden.com).
|
Responses on one single assessment of state-anxiety on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Men's state anxiety
Time Frame: Responses on one single assessment of state-anxiety on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
|
Men's anxiety will be assessed with the 'State Trait Anxiety Inventory, state module (STAI-state; score 20-80, the higher the more anxious)' questionnaire (Spielberger et al, 2015; www.mingarden.com)
|
Responses on one single assessment of state-anxiety on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
|
Women's infertility specific distress
Time Frame: Responses on one single assessment of distress on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
|
Women's infertility-specific distress will be assessed with the reliable 'Infertility Distress Scale (IDS; score 8-40 with the higher, the more distress)' (Pook&Krause, Fertil Steril, 2005)
|
Responses on one single assessment of distress on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
|
Men's infertility specific stress
Time Frame: Responses on one single assessment of distress on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
|
Men's infertility-specific distress will be assessed with the reliable 'Infertility Distress Scale (IDS; score 8-40 with the higher, the more distress)' (Pook&Krause, Fertil Steril, 2005)
|
Responses on one single assessment of distress on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
|
Clinical pregnancy with fetal heart beat
Time Frame: A medium duration after intervention or control condition: 12 weeks after oocyte aspiration
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A pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with a discernible heartbeat (Zegers-Hochschild et al, Hum Reprod, 2017).
|
A medium duration after intervention or control condition: 12 weeks after oocyte aspiration
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Miscarriage after clinical pregnancy with fetal heart beat
Time Frame: A medium duration after intervention or control condition: 12 weeks after oocyte aspiration
|
A miscarriage after a pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with a discernible heartbeat (Zegers-Hochschild et al, Hum Reprod, 2017).
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A medium duration after intervention or control condition: 12 weeks after oocyte aspiration
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Live birth from the first fresh embryo transfer
Time Frame: A long duration after intervention or control condition: One year after oocyte aspiration
|
Dichotomous outcome (yes-no), which is achieved if the first fresh embryo transfer results in a live birth.
More specifically, the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached.
A birth weight of 500 grams or more can be used if gestational age is unknown.
Live births refer to the individual newborn; for example, a twin delivery represents two live births (Zegers-Hochschild et al, Hum Reprod, 2017).
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A long duration after intervention or control condition: One year after oocyte aspiration
|
Clinical pregnancy with fetal heart beat from the frozen embryo transfers of 1st IVF-cycle
Time Frame: A long duration after intervention or control condition: One year after oocyte aspiration
|
Dichotomous outcome (yes-no), which is achieved if at least one clinical pregnancy with fetal heart beat is conceived after the transfer of embryos which have been frozen as a result of the first oocyte aspiration (Zegers-Hochschild et al, Hum Reprod, 2017).
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A long duration after intervention or control condition: One year after oocyte aspiration
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12-months cumulative clinical pregnancy with fetal heart beat
Time Frame: A long duration after intervention or control condition: One year after oocyte aspiration
|
Dichotomous outcome (yes-no), which is achieved if at least one clinical pregnancy with fetal heart beat is conceived within 12-months after oocyte aspiration
|
A long duration after intervention or control condition: One year after oocyte aspiration
|
IVF-delay or number of untreated cycles within 12 months
Time Frame: A long duration after intervention or control condition: One year after oocyte aspiration
|
The number of untreated cycles within 12 months after an unsuccessful oocyte aspiration
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A long duration after intervention or control condition: One year after oocyte aspiration
|
IVF-discontinuation
Time Frame: A long duration after intervention or control condition: One year after oocyte aspiration
|
Dichotomous outcome (yes-no), which is achieved if a couple decides themselves (without censored by their gynaecologist) not to start a second oocyte aspiration within 12 months after their first unsuccessful oocyte aspiration
|
A long duration after intervention or control condition: One year after oocyte aspiration
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Karen Peeraer, PhD, Universitaire Ziekenhuizen KU Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- s61509
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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