Infertility Clinical Trial
— POAM-RCTOfficial title:
The Evaluation of a Preparatory Information Movie on Oocyte Aspiration: a Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 190 |
Est. completion date | October 10, 2020 |
Est. primary completion date | October 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | GZA Ziekenhuizen campus Sint-Augustinus | Wilrijk | Antwerpen |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven | GZA Ziekenhuizen Campus Sint-Augustinus |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Women's state anxiety | 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 | Men's state anxiety | 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. | |
Secondary | Women's infertility specific distress | 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. | |
Secondary | Men's infertility specific stress | 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. | |
Secondary | Clinical pregnancy with fetal heart beat | 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 | |
Secondary | Miscarriage after clinical pregnancy with fetal heart beat | 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). | A medium duration after intervention or control condition: 12 weeks after oocyte aspiration | |
Secondary | Live birth from the first fresh embryo transfer | 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). | A long duration after intervention or control condition: One year after oocyte aspiration | |
Secondary | Clinical pregnancy with fetal heart beat from the frozen embryo transfers of 1st IVF-cycle | 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). | A long duration after intervention or control condition: One year after oocyte aspiration | |
Secondary | 12-months cumulative clinical pregnancy with fetal heart beat | 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 | |
Secondary | IVF-delay or number of untreated cycles within 12 months | The number of untreated cycles within 12 months after an unsuccessful oocyte aspiration | A long duration after intervention or control condition: One year after oocyte aspiration | |
Secondary | IVF-discontinuation | 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 |
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