NCT07310641Completed
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
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
Source: ClinicalTrials.gov · Last updated 5 Jan 2026
Brief summary (registry, in English)
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: 1. Undergone ART procedures including ovarian stimulation, oocyte retrieval, fertilization, embryo biopsy, and transfer of embryos free of the pathogenic mutation. 2. Received genetic counseling and preimplantation genetic testing for monogenic diseases (PGT-M). 3. Been monitored throughout the process for clinical outcomes and complications (e.g., OHSS, pregnancy loss, hypertensive disorders).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 44 (actual)
- First submitted
- 16 Dec 2025
- Start date
- 30 Dec 2024
- Primary completion date
- 6 May 2025
- Lead sponsor
- Azienda Sanitaria Universitaria Integrata del Trentino
- Diseases
- Polycystic kidney disease
- NCT number
- NCT07310641
What you commit to
- Study type: Observational
- Participants enrolled: 44
- From 30 Dec 2024 to the primary completion date, 6 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- \> 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale di Arco Coordinator of this site? Confirm its status | Arco | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.