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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Infertility

Treatments: Other: Control group; Other: Gynecologists' feedback on ART-Birth rates

Study type: Interventional

Funder types: Other

Identifiers

NCT04169295

s62972

Details and patient eligibility

About

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).

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Intervention group

Experimental group

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

Treatment:

Other: Gynecologists' feedback on ART-Birth rates

Control group

Sham Comparator group

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.

Treatment:

Other: Control group