Polycystic Kidney DiseasePGT-M PKDNCT07310641
Descriptive Analysis of Preimplantation Genetic Test (PGT)in Couples With Polycystic Kidney Disease (PKD). In the ADPKD Subgroup Evaluation of Outcomes and Complications Comparing Couples in Which the Father is Affected With Couples in Which the Mother is Affected
An observational study of Polycystic Kidney Disease and Assisted Reproductive Technology, run by Azienda Sanitaria Universitaria Integrata del Trentino at 1 site in Italy.
Trial summary
The goal of this observational study is to evaluate the outcomes of assisted reproductive technology (ART) combined with preimplantation genetic testing for monogenic diseases (PGT-M) in couples affected by or carriers of polycystic kidney disease (PKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycystic Kidney Disease, Assisted Reproductive Technology, Preimplantation Genetic Testing (PGT)
- What is being tested?
- Assisted reproductive technology and preimplantation diagnosis for monogenic diseases
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 30 Dec 2024to 6 May 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Couples carrying polycystic kidney disease referred to the ART center at Arco Hospital, seeking to undergo preimplantation genetic testing and achieve a pregnancy.
Who may be able to join
- > 18 years old
- Member of a heterosexual couple in which one of the two individuals is affected by ADPKD (with the condition confirmed by genetic diagnosis), or in which both members are carriers of ARPKD (with the condition genetically confirmed), who have been taken in charge by the Arco Medically Assisted Procreation (MAP) Center between January 1, 2018, and August 1, 2024, for the purpose of preimplantation genetic testing for monogenic diseases (PGT-M).
- Couples in which both partners have given their consent to participate in the study and to the processing of personal data.
Who cannot join
- Minors
- Couples in which one or both members have not given their consent to participate in the study and to the processing of personal data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Analysis of Couples With Polycystic Kidney Disease (PKD) Accessing the Arco Hospital Assisted Reproductive Technology Center for Preimplantation Testing and Comparing Outcomes and Complications in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Couples in Which the Male is a Carrier of the Disease Versus Couples in Which the Female is a Carrier
The goal of this observational study is to evaluate the outcomes of assisted reproductive technology (ART) combined with preimplantation genetic testing for monogenic diseases (PGT-M) in couples affected by or carriers of polycystic kidney disease (PKD). The participant population includes couples in which one partner has autosomal dominant polycystic kidney disease (ADPKD) or both partners have autosomal recessive polycystic kidney disease (ARPKD), who were treated at the Arco Medically Assisted Procreation Center (part of Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento) between January 1, 2018, and August 1, 2024, and who provided informed consent to participate in the study.
The main questions it aims to answer were:
Read more
- What are the outcomes in terms of clinical pregnancy and live birth rates in this population undergoing ART with PGT-M?
- What is the incidence of complications, including ovarian hyperstimulation syndrome (OHSS), miscarriage, hypertension, and preeclampsia, in these patients?
There is no external comparison group; however, the study may perform internal comparisons between subgroups (e.g., ADPKD vs ARPKD couples) to assess whether specific forms of PKD are associated with different reproductive outcomes.
Participants have:
- Undergone ART procedures including ovarian stimulation, oocyte retrieval, fertilization, embryo biopsy, and transfer of embryos free of the pathogenic mutation.
- Received genetic counseling and preimplantation genetic testing for monogenic diseases (PGT-M).
- Been monitored throughout the process for clinical outcomes and complications (e.g., OHSS, pregnancy loss, hypertensive disorders).
- Conditions
- Polycystic Kidney Disease, Assisted Reproductive Technology, Preimplantation Genetic Testing (PGT)
- Being tested
- Assisted reproductive technology and preimplantation diagnosis for monogenic diseases
- Medical subject headings
- Polycystic Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted reproductive technology and preimplantation diagnosis for monogenic diseasesProcedure or surgery
Assisted reproductive technology and preimplantation diagnosis for monogenic diseases
| Study group | Role | What they receive |
|---|---|---|
| Subjects with autosomal dominant polycystic kidney disease | Not described Receives: Procedure: Assisted reproductive technology and preimplantation diagnosis for monogenic diseases | |
| Subjects with autosomal recessive polycystic kidney disease | Not described Receives: Procedure: Assisted reproductive technology and preimplantation diagnosis for monogenic diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth or ongoing pregnancy at term during the observation period
Measured: From January 2018 to July 2024
Secondary outcomes (4)
Live birth - ongoing pregnancy
Measured: From January 2018 to July 2024
Number and percentage of preterm births (<37 weeks) in each cohort
Measured: From January 2018 to July 2024
Incidence of pregnancy complications in the two cohorts
Measured: From January 2018 to July 2024
Number of miscarriages in each cohort
Measured: From January 2018 to July 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start30 Dec 2024
- Primary completion6 May 2025
- Study completion6 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Kidney DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Universitaria Integrata del Trentino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310641
- Sponsor's protocol ID
- 28258
- Acronym
- PGT-M PKD
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Analysis of Couples With Polycystic Kidney Disease (PKD) Accessing the Arco Hospital Assisted Reproductive Technology Center for Preimplantation Testing and Comparing Outcomes and Complications in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Couples in Which the Male is a Carrier of the Disease Versus Couples in Which the Female is a Carrier
- ClinicalTrials.gov ID
- NCT07310641
- Acronym / sponsor ID
- PGT-M PKD / 28258
- Conditions
- Polycystic Kidney Disease, Assisted Reproductive Technology, Preimplantation Genetic Testing (PGT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Azienda Sanitaria Universitaria Integrata del TrentinoUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 30 Dec 2025 (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.
The goal of this observational study is to evaluate the outcomes of assisted reproductive technology (ART) combined with preimplantation genetic testing for monogenic diseases (PGT-M) in couples affected by or carriers of polycystic kidney disease (PKD). The participant population includes couples in which one partner has autosomal dominant polycystic kidney disease (ADPKD) or both partners have autosomal recessive polycystic kidney disease (ARPKD), who were treated at the Arco Medically Assisted Procreation Center (part of Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento) between January 1, 2018, and August 1, 2024, and who provided informed consent to participate in the study.
The main questions it aims to answer were:
- What are the outcomes in terms of clinical pregnancy and live birth rates in this population undergoing ART with PGT-M?
- What is the incidence of complications, including ovarian hyperstimulation syndrome (OHSS), miscarriage, hypertension, and preeclampsia, in these patients?
There is no external comparison group; however, the study may perform internal comparisons between subgroups (e.g., ADPKD vs ARPKD couples) to assess whether specific forms of PKD are associated with different reproductive outcomes.
Participants have:
- Undergone ART procedures including ovarian stimulation, oocyte retrieval, fertilization, embryo biopsy, and transfer of embryos free of the pathogenic mutation.
- Received genetic counseling and preimplantation genetic testing for monogenic diseases (PGT-M).
- Been monitored throughout the process for clinical outcomes and complications (e.g., OHSS, pregnancy loss, hypertensive disorders).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with autosomal dominant polycystic kidney disease | – | Procedure: Assisted reproductive technology and preimplantation diagnosis for monogenic diseases |
| Subjects with autosomal recessive polycystic kidney disease | – | Procedure: Assisted reproductive technology and preimplantation diagnosis for monogenic diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Couples carrying polycystic kidney disease referred to the ART center at Arco Hospital, seeking to undergo preimplantation genetic testing and achieve a pregnancy.
Key inclusion criteria (3 listed)
- > 18 years old
- Member of a heterosexual couple in which one of the two individuals is affected by ADPKD (with the condition confirmed by genetic diagnosis), or in which both members are carriers of ARPKD (with the condition genetically confirmed), who have been taken in charge by the Arco Medically Assisted Procreation (MAP) Center between January 1, 2018, and August 1, 2024, for the purpose of preimplantation genetic testing for monogenic diseases (PGT-M).
- Couples in which both partners have given their consent to participate in the study and to the processing of personal data.
Key exclusion criteria (2 listed)
- Minors
- Couples in which one or both members have not given their consent to participate in the study and to the processing of personal data
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 |
|---|---|---|
| Assisted reproductive technology and preimplantation diagnosis for monogenic diseasesAssisted reproductive technology and preimplantation diagnosis for monogenic diseases | Procedure or surgery | Subjects with autosomal dominant polycystic kidney disease, Subjects with autosomal recessive polycystic kidney disease |
Primary outcome
Live birth or ongoing pregnancy at term during the observation period
Time frame: From January 2018 to July 2024
4 secondary outcomes
Live birth - ongoing pregnancy
Time frame: From January 2018 to July 2024
Number and percentage of preterm births (<37 weeks) in each cohort
Time frame: From January 2018 to July 2024
Incidence of pregnancy complications in the two cohorts
Time frame: From January 2018 to July 2024
Number of miscarriages in each cohort
Time frame: From January 2018 to July 2024
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 5 Jan 2026.
Related trials for Polycystic Kidney Disease
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Recruiting
Well-Formulated Ketogenic Diet Polycystic Kidney Disease
Polycystic Kidney Disease
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Kidney Disease and Assisted Reproductive Technology, run by Azienda Sanitaria Universitaria Integrata del Trentino at 1 site in Italy.
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 3 inclusion and 2 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 5 Jan 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 Italy. 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?
Live birth or ongoing pregnancy at term during the observation period (time frame: From January 2018 to July 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2026.