Clinical trial NCT04169295: Gynecologists' Feedback on ART-Birth Rates
Official title: Gynecologists' Feedback on Assisted Reproductive Technology (ART) Birth Rates: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: GZA Ziekenhuizen Campus Sint-Augustinus
First posted: 2019-11-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The proportion of women over-estimating their IVF-live birth rate
timeFrame: 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:
measure: The proportion of men over-estimating their IVF-live birth rate
timeFrame: Patient's expected IVF-live birth rate will be assessed immediately after the fresh embryo transfer with a single question coded paper-pencil questionnaire.
measure: Women's and men's anxiety
timeFrame: 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)
measure: Women's and men's infertility-specific distress
timeFrame: 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:
measure: Live birth rate of the observed IVF-cycle
timeFrame: Within 12-months after the oocyte aspiration of the observed IVF-cycle
measure: IVF-delay
timeFrame: Within 12-months after the oocyte aspiration of the observed IVF-cycle
measure: IVF-discontinuation
timeFrame: Within 12-months after the oocyte aspiration of the observed IVF-cycle
Locations:
city: Leuven
country: Belgium
facility: Leuven University Fertility Center
state: Vlaams Brabant
Study officials:
affiliation: Leuven University Fertilitycentre
name: Karen Peeraer, Prof.
role: PRINCIPAL_INVESTIGATOR
References: