Gynecologists' Feedback on ART-Birth Rates

Infertility Clinical Trial

— GAB-RCT  

Official title:

Gynecologists' Feedback on Assisted Reproductive Technology (ART) Birth Rates: a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04169295
• Other study ID #: s62972
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 22, 2019
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: September 1, 2023
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Gynecologists' feedback on ART-Birth rates
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.
• Control group
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

Locations

Country	Name	City	State
Belgium	Leuven University Fertility Center	Leuven	Vlaams Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	GZA Ziekenhuizen Campus Sint-Augustinus

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Live birth rate of the observed IVF-cycle	Cumulative clinical live birth rates after all embryo transfers resulting from the oocyte aspiration of the observed IVF-cycle	Within 12-months after the oocyte aspiration of the observed IVF-cycle
Other	IVF-delay	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	Within 12-months after the oocyte aspiration of the observed IVF-cycle
Other	IVF-discontinuation	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	Within 12-months after the oocyte aspiration of the observed IVF-cycle
Primary	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	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.	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	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.	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)
Secondary	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	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)