Gynecologists' Feedback on ART-Birth Rates

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Other: Gynecologists' feedback on ART-Birth rates
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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.<br>|
| Sham Comparator: Control group<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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) | 
| 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) |