Viewing Study NCT03717805



Ignite Creation Date: 2024-05-06 @ 12:16 PM
Last Modification Date: 2024-10-26 @ 12:56 PM
Study NCT ID: NCT03717805
Status: COMPLETED
Last Update Posted: 2024-07-03
First Post: 2018-10-10

Brief Title: The Evaluation of a Preparatory Information Movie on Oocyte Aspiration
Sponsor: Universitaire Ziekenhuizen KU Leuven
Organization: Universitaire Ziekenhuizen KU Leuven

Study Overview

Official Title: The Evaluation of a Preparatory Information Movie on Oocyte Aspiration a Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2024-07
Last Known Status: Recruiting
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: POAM-RCT
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 Womens 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 mens anxiety and both partners 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 ie 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
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 womens 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 mens 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 ie 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 ie 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 ie 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None