Gynecologists' Feedback on ART-Birth Rates

NCT04169295 | Completed

• 1 other identifier: s62972
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will examine the hypothesis that women who are given their personalized IVF-prognosis are less likely to overestimate their IVF-live birth rate, as compared to women who do not receive a personalized IVF-prognosis. Control group: At the time of their fresh embryo transfer couples will receive a document with a photo of their transferred embryo(s) and the number of cryopreserved embryos. Intervention group: At the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo, the number of cryopreserved embryos, the quality rating of the transferred embryo's, and couple's personalized IVF-prognosis (i.e. their chance on a live birth from the current IVF-cycle, including the transfer of fresh and if available cryopreserved embryos, calculated by entering eight background characteristics and five IVF-laboratory results into a prognostic model).

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• The proportion of women over-estimating their IVF-live birth rate

  The proportion of women expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer.

  Patient's expected IVF-live birth rate will be assessed immediately after the fresh embryo transfer with a single question coded paper-pencil questionnaire.

Secondary Outcomes (3)

• The proportion of men over-estimating their IVF-live birth rate

  Patient's expected IVF-live birth rate will be assessed immediately after the fresh embryo transfer with a single question coded paper-pencil questionnaire.

• Women's and men's anxiety

  Anxious feelings immediately after the fresh embryo transfer are assessed with the coded paper-pencil State Trait Anxiety Inventory, state module (STAI-state; 20-80, the higher, the more anxious)

• Women's and men's infertility-specific distress

  Infertility specific distress within 2 days of the conclusive pregnancy test after the the last embryotransfer (fresh or cryo) assessed with the Infertility Distress Scale (IDS; 8-40; the higher the more infertility specific distress)

Other Outcomes (3)

• Live birth rate of the observed IVF-cycle

  Within 12-months after the oocyte aspiration of the observed IVF-cycle

• IVF-delay

  Within 12-months after the oocyte aspiration of the observed IVF-cycle

• IVF-discontinuation

  Within 12-months after the oocyte aspiration of the observed IVF-cycle

Study Arms (2)

Intervention group

EXPERIMENTAL

At the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo, the number of cryopreserved embryos, the quality rating of the transferred embryo's, and couple's personalized IVF-prognosis

Other: Gynecologists' feedback on ART-Birth rates

Control group

SHAM COMPARATOR

At the time of their fresh embryo transfer couples will receive a document with a photo of their transferred embryo(s) and the number of cryopreserved embryos.

Other: Control group

Interventions

Gynecologists' feedback on ART-Birth rates OTHER

At the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo, the number of cryopreserved embryos, the quality rating of the transferred embryo's and couple's personalized IVF-prognosis (i.e. their chance on a live birth from the current IVF-cycle, including the transfer of fresh and if available cryopreserved embryos), calculated by entering eight background characteristics and five IVF-laboratory results into a prognostic model.

Intervention group

Control group OTHER

At the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo and the number of cryopreserved embryos

Control group

Eligibility Criteria

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

You may qualify if:

• Couples treated with a 2nd-6th fresh cycle of IVF (every couple can only participate ones in this study).

You may not qualify if:

• Couples treated with:
• Pre-implantation Genetic Testing (PGT)
• donated oocytes, sperm or embryos
• Spermatozoa obtained by testicular extraction
• HIV-positive diagnosis
• Embryo transfer on day 2

Sponsors & Collaborators

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

Study Sites (1)

Leuven University Fertility Center

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Infertility

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Karen Peeraer, Prof.

  Leuven University Fertilitycentre

  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

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 19, 2019
• Study Start: November 22, 2019
• Primary Completion: January 26, 2022
• Study Completion: May 17, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)