Patient EducationPGT-ANCT06018454
Preimplantation Genetic Testing for Aneuploidy Counseling
A study testing Handout on PGT-A and Handout on PGT-A and genetic counseling in people with Patient Education, run by Eyup Hakan Duran at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Education
- What is being tested?
- Handout on PGT-A and Handout on PGT-A and genetic counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2022to 29 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing in vitro fertilization (IVF)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preimplantation Genetic Testing for Aneuploidy (PGT-A) Counseling for Patients Undergoing in Vitro Fertilization (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.
Read the detailed description
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.
- Conditions
- Patient Education
- Being tested
- Handout on PGT-A, Handout on PGT-A and genetic counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handout on PGT-AOther
Educational handout on PGT-A
Handout on PGT-A and genetic counselingOther
Handout on PGT-A and genetic counseling session with a genetic counselor on PGT-A
| Study group | Role | What they receive |
|---|---|---|
| Provider counseling with pre-test | No intervention | Counseling regarding PGT-A only with a provider(current standard of care), pre-test provided. |
| Handout on PGT-A and provider counseling with pre-test | Experimental | Counseling regarding PGT-A with a provider and review of a handout(educational intervention), pre-test provided. Receives: Other: Handout on PGT-A |
| Handout on PGT-A, provider counseling and brief genetic counselor counseling with pre-test | Experimental | Counseling regarding PGT-A only with a provider, review of a handout(educational intervention) and genetic counseling (counseling intervention), pre-test provided. Receives: Other: Handout on PGT-A; Other: Handout on PGT-A and genetic counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
PGT-A Knowledge scores
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
Measured: Prior to new IVF visit
PGT-A Knowledge scores
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
Measured: Immediately following new IVF visit
PGT-A Knowledge scores
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
Measured: Two weeks post IVF visit.
Secondary outcomes (1)
Decisional conflict as measured by the SURE questionnaire.
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.
Measured: Two weeks post IVF visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start20 Dec 2022
- Primary completion30 Oct 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Patient EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomized with computer generated block randomization of ratio 1:1:1 to randomize women to either 10 minute genetic counseling intervention with handout, handout, or no interventions. Randomization allocation will be performed prior to study initiation through the Institute for Clinical and Translational Science (ICTS) via REDCap software.
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyup Hakan Duran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eyup Hakan Duran, University of Iowa
- Investigators
- Prapti Singh, DO, Study director, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018454
- Sponsor's protocol ID
- 202208644
- Acronym
- PGT-A
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26474735Lee 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.
PubMed 33040985Kaing 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.
PubMed 32756971Quinn 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.
PubMed 30334131McGowan 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.
PubMed 19652605Early 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.
PubMed 32472448Early 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.
PubMed 34806131Singh 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.
PubMed 40523553
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preimplantation Genetic Testing for Aneuploidy (PGT-A) Counseling for Patients Undergoing in Vitro Fertilization (IVF)
- ClinicalTrials.gov ID
- NCT06018454
- Acronym / sponsor ID
- PGT-A / 202208644
- Conditions
- Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Eyup Hakan DuranUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients randomized with computer generated block randomization of ratio 1:1:1 to randomize women to either 10 minute genetic counseling intervention with handout, handout, or no interventions. Randomization allocation will be performed prior to study initiation through the Institute for Clinical and Translational Science (ICTS) via REDCap software.
| Arm | Type | Receives |
|---|---|---|
| Provider counseling with pre-test | No intervention | –Counseling regarding PGT-A only with a provider(current standard of care), pre-test provided. |
| Handout on PGT-A and provider counseling with pre-test | Experimental | Other: Handout on PGT-ACounseling regarding PGT-A with a provider and review of a handout(educational intervention), pre-test provided. |
| Handout on PGT-A, provider counseling and brief genetic counselor counseling with pre-test | Experimental | Other: Handout on PGT-A, Other: Handout on PGT-A and genetic counselingCounseling regarding PGT-A only with a provider, review of a handout(educational intervention) and genetic counseling (counseling intervention), pre-test provided. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing in vitro fertilization (IVF)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handout on PGT-AEducational handout on PGT-A | Other | Handout on PGT-A and provider counseling with pre-test, Handout on PGT-A, provider counseling and brief genetic counselor counseling with pre-test |
| Handout on PGT-A and genetic counselingHandout on PGT-A and genetic counseling session with a genetic counselor on PGT-A | Other | Handout on PGT-A, provider counseling and brief genetic counselor counseling with pre-test |
Primary outcome
PGT-A Knowledge scores
Time frame: Prior to new IVF visit
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
PGT-A Knowledge scores
Time frame: Immediately following new IVF visit
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
PGT-A Knowledge scores
Time frame: Two weeks post IVF visit.
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
1 secondary outcome
Decisional conflict as measured by the SURE questionnaire.
Time frame: Two weeks post IVF visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 26474735Gebhart 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.
- Background: PubMed 33040985Lee 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.
- Background: PubMed 32756971Kaing 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.
- Background: PubMed 30334131Quinn 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.
- Background: PubMed 19652605McGowan 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.
- Background: PubMed 32472448Early 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.
- Background: PubMed 34806131Early 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.
- Derived from this study: PubMed 40523553Singh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prapti Singh, DO study director
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handout on PGT-A and Handout on PGT-A and genetic counseling in people with Patient Education, run by Eyup Hakan Duran at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PGT-A Knowledge scores (time frame: Prior to new IVF visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06018454, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.