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Gynecologists' Feedback on ART-Birth Rates (GAB-RCT)

Primary Purpose

Infertility

Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Gynecologists' feedback on ART-Birth rates
Control group
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Leuven University Fertility Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The proportion of men over-estimating their IVF-live birth rate
The proportion of men expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer.
Women's and men's anxiety
Women's and men's anxiety will be assessed with the reliable STAI-state questionnaire, disseminated in coded paper-pencil format on the day of the fresh embryo transfer.
Women's and men's infertility-specific distress
Women's and men's infertility-specific distress will be assessed with the reliable 'Infertility Distress Scale (IDS)' questionnaire, disseminated via text message and online

Full Information

First Posted
November 12, 2019
Last Updated
January 16, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
GZA Ziekenhuizen Campus Sint-Augustinus
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1. Study Identification

Unique Protocol Identification Number
NCT04169295
Brief Title
Gynecologists' Feedback on ART-Birth Rates
Acronym
GAB-RCT
Official Title
Gynecologists' Feedback on Assisted Reproductive Technology (ART) Birth Rates: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
January 26, 2022 (Actual)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
GZA Ziekenhuizen Campus Sint-Augustinus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Primary outcome: The proportion of women expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer. Secondary outcomes: The proportion of men expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer. Women's and men's anxiety will be assessed with the reliable 'State-Anxiety Inventory, (STAI-state)' questionnaire, disseminated in coded paper-pencil format on the day of the fresh embryo transfer. Patient's infertility-specific distress will be assessed with the reliable 'Infertility Distress Scale (IDS)' questionnaire, within two days of the conclusive pregnancy test after the transfer of the last (fresh or cryopreserved) embryo of the studied IVF-cycle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Gynecologists' feedback on ART-Birth rates
Intervention Description
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 Type
Other
Intervention Name(s)
Control group
Intervention Description
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
Primary Outcome Measure Information:
Title
The proportion of women over-estimating their IVF-live birth rate
Description
The proportion of women expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer.
Time Frame
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 Outcome Measure Information:
Title
The proportion of men over-estimating their IVF-live birth rate
Description
The proportion of men expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer.
Time Frame
Patient's expected IVF-live birth rate will be assessed immediately after the fresh embryo transfer with a single question coded paper-pencil questionnaire.
Title
Women's and men's anxiety
Description
Women's and men's anxiety will be assessed with the reliable STAI-state questionnaire, disseminated in coded paper-pencil format on the day of the fresh embryo transfer.
Time Frame
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)
Title
Women's and men's infertility-specific distress
Description
Women's and men's infertility-specific distress will be assessed with the reliable 'Infertility Distress Scale (IDS)' questionnaire, disseminated via text message and online
Time Frame
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 Pre-specified Outcome Measures:
Title
Live birth rate of the observed IVF-cycle
Description
Cumulative clinical live birth rates after all embryo transfers resulting from the oocyte aspiration of the observed IVF-cycle
Time Frame
Within 12-months after the oocyte aspiration of the observed IVF-cycle
Title
IVF-delay
Description
Number of untreated cycles prior to the start of a new fresh IVF-cycle after the last negative pregnancy test of the observed IVF-cycle
Time Frame
Within 12-months after the oocyte aspiration of the observed IVF-cycle
Title
IVF-discontinuation
Description
Whether or not a subsequent IVF-cycle was started within twelve months after the last negative pregnancy test of the observed IVF-cycle and while no medical censoring to discontinue
Time Frame
Within 12-months after the oocyte aspiration of the observed IVF-cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Couples treated with a 2nd-6th fresh cycle of IVF (every couple can only participate ones in this study). Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Peeraer, Prof.
Organizational Affiliation
Leuven University Fertilitycentre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leuven University Fertility Center
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Gynecologists' Feedback on ART-Birth Rates

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