Preimplantationsgenetisk testning för aneuploidirådgivning (PGT-A)
Preimplantation genetisk testning för aneuploidi (PGT-A) rådgivning för patienter som genomgår in vitro fertilisering (IVF)
Purpose: To evaluate preimplantation genetic testing counseling interventions on patients undergoing in vitro fertilization treatment.
Preimplantation genetic testing for aneuploidy (PGT) allows patients undergoing in vitro fertilization (IVF) to screen embryos for genetic disorders. Preimplantation genetic testing for aneuploidy (PGT-A) is the testing most commonly ordered, and it screens for whole chromosome and large partial chromosome duplications or deletions. Currently, patient counseling varies based on the clinic, ranging from appointments to group seminars with a genetic counselor (GC), geneticist or reproductive endocrinology and infertility (REI) physicians for education regarding PGT. Patient knowledge regarding PGT has been varied with some studies indicating sufficient knowledge, while other studies have shown a potential lack of knowledge. One study indicated a third of patients had regret regarding their decision of whether or not to use PGT-A during IVF and another study indicated patients who choose to undergo PGT did so for reasons that were not evidence based. Additionally, educational materials have been illustrated to be inconsistent and with inappropriate literacy in regards to PGT counseling. One study has shown the potential of improvement with written intervention amongst providers and patients in regards to PGT related to a single genetic condition. The investigators hope to assess the efficacy of PGT-A educational and counseling interventions on patients undergoing IVF.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Procedures: Patients undergoing IVF for the first time will be randomized to one of three groups
- Provider counseling (current standard care) with pre-test
- Handout on PGT-A and provider counseling (current standard care + educational intervention) with pre-test
- Handout on PGT-A, provider counseling and brief genetic counselor counseling (current standard of care + educational and counseling interventions) with pre-test
All patients will receive provider counseling(current standard of care) on PGT-A during their new IVF clinic visit. All groups will take a pre-test on PGT-A prior to receiving provider counseling and (if in an intervention group) prior to receiving handout or handout with brief counseling on PGT-A from a genetic counselor. At the end of their clinic visit, all participants will complete a post-test on PGT-A.
Two weeks after their clinic visit, all participants will receive a 2nd post-test on PGT-A and the SURE questionnaire to assess retained knowledge about PGT-A and decisional conflict about their choice to use PGT-A in their treatment cycle.
As there is not a validated knowledge survey for PGT-A, investigators have developed their own for pre- and post-tests. In order to validate the survey prior to using it in this study, investigators plan to enroll the first 100 participants in a pilot study to validate the instrument. The number needed for validation will depend on how much pilot participants scores vary between pre and post test. Participants in the pilot portion of the study will be asked to complete a pre-test on PGT-A, read the informational handout about PGT-A, and then complete a post test on PGT-A prior to their IVF appointment. Statisticians will analyze the pilot data as received, and will inform investigators when a sufficient number has been reached for survey validation. Once validated, the pilot arm of the study will be closed and will begin enrolling participants in the randomized trial portion described above.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Iowa
-
Iowa City, Iowa, Förenta staterna, 52245
- University of Iowa
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients undergoing in vitro fertilization (IVF)
Exclusion Criteria:
- Patients who have previously undergone IVF would be excluded.
- Patients who have previously discussed PGT with a genetic counselor would be excluded.
- Patients who do not speak English will be excluded.
- Patients who are employees of the clinic would be excluded.
- Patients who have an indication for PGT-M or PGT-SR would be excluded.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Provider counseling with pre-test
Counseling regarding PGT-A only with a provider(current standard of care), pre-test provided. |
|
|
Experimentell: Handout on PGT-A and provider counseling with pre-test
Counseling regarding PGT-A with a provider and review of a handout(educational intervention), pre-test provided. |
Educational handout on PGT-A |
|
Experimentell: Handout on PGT-A, provider counseling and brief genetic counselor counseling with pre-test
Counseling regarding PGT-A only with a provider, review of a handout(educational intervention) and genetic counseling (counseling intervention), pre-test provided. |
Educational handout on PGT-A Handout on PGT-A and genetic counseling session with a genetic counselor on PGT-A |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PGT-A Knowledge scores
Tidsram: Prior to new IVF visit
|
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7. |
Prior to new IVF visit
|
|
PGT-A Knowledge scores
Tidsram: Immediately following new IVF visit
|
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7. |
Immediately following new IVF visit
|
|
PGT-A Knowledge scores
Tidsram: Two weeks post IVF visit.
|
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7. |
Two weeks post IVF visit.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Decisional conflict as measured by the SURE questionnaire.
Tidsram: Two weeks post IVF visit.
|
A validated questionnaire assessing patient decisional conflict on a scale of 0 to 4. Zero indicating no decisional conflict and 1 or greater indicating increasing levels of decisional conflict. |
Two weeks post IVF visit.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Prapti Singh, DO, University of Iowa
Publikationer och användbara länkar
Allmänna publikationer
- Gebhart MB, Hines RS, Penman A, Holland AC. How do patient perceived determinants influence the decision-making process to accept or decline preimplantation genetic screening? Fertil Steril. 2016 Jan;105(1):188-93. doi: 10.1016/j.fertnstert.2015.09.022. Epub 2015 Oct 24.
- Lee I, Alur-Gupta S, Gallop R, Dokras A. Utilization of preimplantation genetic testing for monogenic disorders. Fertil Steril. 2020 Oct;114(4):854-860. doi: 10.1016/j.fertnstert.2020.05.045.
- Kaing A, Rosen MP, Quinn MM. Perceptions, motivations and decision regret surrounding preimplantation genetic testing for aneuploidy. Hum Reprod. 2020 Sep 1;35(9):2047-2057. doi: 10.1093/humrep/deaa154.
- Quinn MM, Juarez-Hernandez F, Dunn M, Okamura RJ, Cedars MI, Rosen MP. Decision-making surrounding the use of preimplantation genetic testing for aneuploidy reveals misunderstanding regarding its benefit. J Assist Reprod Genet. 2018 Dec;35(12):2155-2159. doi: 10.1007/s10815-018-1337-8. Epub 2018 Oct 18.
- McGowan ML, Burant CJ, Moran R, Farrell R. Patient education and informed consent for preimplantation genetic diagnosis: health literacy for genetics and assisted reproductive technology. Genet Med. 2009 Sep;11(9):640-5. doi: 10.1097/GIM.0b013e3181ac6b52.
- Early ML, Kumar P, Marcell AV, Lawson C, Christianson M, Pecker LH. Literacy assessment of preimplantation genetic patient education materials exceed national reading levels. J Assist Reprod Genet. 2020 Aug;37(8):1913-1922. doi: 10.1007/s10815-020-01837-z. Epub 2020 May 29.
- Early ML, Strodel RJ, Lake IV, Ruddy JA, Saba JA, Singh SM, Lanzkron S, Mack JW, Meier ER, Christianson MS, Pecker LH. Acceptable, hopeful, and useful: development and mixed-method evaluation of an educational tool about reproductive options for people with sickle cell disease or trait. J Assist Reprod Genet. 2022 Jan;39(1):183-193. doi: 10.1007/s10815-021-02358-z. Epub 2021 Nov 22.
- Singh P, Summers KM, Chanouha N, Thoeny R, Zorn A, Van Voorhis BJ, Sparks AE, Eapen A, Faro EZ, Pawlak SA, Duran EH. A randomized controlled trial of counseling and educational methods on preimplantation genetic testing for aneuploidy for patients pursuing in vitro fertilization. Fertil Steril. 2025 Nov 15;124(5 Pt 2):964-973. doi: 10.1016/j.fertnstert.2025.06.010. Epub 2025 Jun 14.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
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Andra studie-ID-nummer
- 202208644
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