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The Evaluation of a Preparatory Information Movie on Oocyte Aspiration (POAM-RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717805
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
GZA Ziekenhuizen Campus Sint-Augustinus
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
The Preparatory information on Oocyte Aspiration Movie Randomized Controlled Trial (POAM-RCT) primarily aims to evaluate whether a new preparatory information on oocyte aspiration movie (POAM) decreases the anxiety of women on the day of their first oocyte aspiration for in vitro fertilisation (IVF). The control group of this RCT will receive care as usual. The intervention group will additional be given access to a preparatory information movie on oocyte aspiration 1-3 days before their oocyte aspiration via a secured link. Women's anxiety will be assessed with the 'State module of the State Trait Anxiety Inventory (STAI-state)' upon arrival at the fertility clinic on the day of the oocyte aspiration. At the same time other questionnaires will be administered. More specifically, men's anxiety and both partner's infertility specific distress will be assessed. In addition, to these secondary outcomes, clinical pregnancy with fetal heart beat and miscarriage will be followed-up 12 weeks after the oocyte aspiration. Finally, treatment delay and treatment discontinuation and 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) will be followed-up twelve months after oocyte aspiration. This RCT will include 190 women (and their male partners) treated with a 1st cycle of IVF (with or without ICSI and PGD). Analysis will be according to intention to treat.

Condition or disease Intervention/treatment Phase
Infertility Other: POAM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial (1/1)
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: The Evaluation of a Preparatory Information Movie on Oocyte Aspiration: a Randomized Controlled Trial
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : October 10, 2020
Estimated Study Completion Date : October 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Infertility

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.
Other: POAM
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).



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. Clinical pregnancy with fetal heart beat [ Time Frame: A medium duration after intervention or control condition: 12 weeks after oocyte aspiration ]
    A pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with a discernible heartbeat (Zegers-Hochschild et al, Hum Reprod, 2017).

  5. 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).

  6. 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).

  7. 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).

  8. 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

  9. 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

  10. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717805


Contacts
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Contact: Eline Dancet, PhD 0032479635711 eline.dancet@kuleuven.be
Contact: Myriam Welkenhuysen, Msc 00316433544 myriam.welkenhuysen@uzleuven.be

Locations
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Belgium
GZA Ziekenhuizen campus Sint-Augustinus Recruiting
Wilrijk, Antwerpen, Belgium, 2610
Contact: Louise Dias    03/443.35.49    louise.dias@gza.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
GZA Ziekenhuizen Campus Sint-Augustinus
Investigators
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Principal Investigator: Karen Peeraer, PhD Universitaire Ziekenhuizen Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03717805    
Other Study ID Numbers: s61509
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
Patient-centered care
Patient information
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female