The Evaluation of a Preparatory Information Movie on Oocyte Aspiration

NCT03717805 | Completed

• 1 other identifier: s61509
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Patient-centered care; Patient information

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Men's state anxiety

  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

  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

  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

  A medium duration after intervention or control condition: 12 weeks after oocyte aspiration

• Miscarriage after clinical pregnancy with fetal heart beat

  A medium duration after intervention or control condition: 12 weeks after oocyte aspiration

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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).

Interventions

POAM OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (i) Heterosexual woman and her partner
• (ii) Dutch speaking
• (iii) Treated with a 1st cycle of IVF (IVF or ICSI; with or without PGD)

You may not qualify if:

• (i) Having already experienced an IVF-cycle in the same of another clinic

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• GZA Ziekenhuizen Campus Sint-Augustinus: collaborator

Study Sites (1)

GZA Ziekenhuizen campus Sint-Augustinus

Wilrijk, Antwerpen, 2610, Belgium

Location

Related Publications (1)

• Dias L, De Loecker P, Willems S, D'Hooghe TM, Vriens J, Peeraer K, Dancet EAF. A video clip detailing the patient journey on the day of oocyte retrieval in addition to the standard of care: a randomized controlled trial. Hum Reprod. 2025 Apr 1;40(4):664-674. doi: 10.1093/humrep/deaf033.

  PMID: 40056004 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Karen Peeraer, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial (1/1)

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 24, 2018
• Study Start: October 29, 2018
• Primary Completion: September 24, 2020
• Study Completion: September 24, 2022
• Last Updated: August 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)