NCT06358547 Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years
| NCT ID | NCT06358547 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 590 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 590 participants in total. It began in 2024-08-01 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A multinational multi-centre, randomized, controlled non-blinded trial with participation of three fertility clinics in Denmark and one in Spain to assess the efficacy and safety of preimplantation genetic testing for aneuploidy (PGT-A) in 37-41-year-old women.
Eligibility Criteria
Inclusion Criteria: * Women aged 37-41 years with a male partner, a female partner og undergoing fertility with no partner. * Anti Müllerian Hormone (AMH) ≥6.28 pmol/L (AMH should be measured no more than one year prior to study inclusion). The optimal is to use the Elecsys® Assay. If other assays are used this should be reported to the investigator and the AMH cut-off level may appropriately be changed so that it corresponds to the cut-off used in the Elecsys® Assay. * IVF/ICSI cycle number 1-5 (previous IVF/ICSI cycles will not count if the woman is recruited after an IVF/ICSI/FET-delivery). Exclusion Criteria: * PGT-SR or PGT-M. * Testicular sperm aspiration (TESA), testicular sperm extraction (TESE), micro-TESE (or cryopreserved sperm from these procedures). * Males with severely compromised semen quality (\<1 million progressively motile sperm cells following gradient centrifugation). * Endometriosis stage three or four. * Women with severe thyroid disease (women can be included if they have normal thyroid levels on relevant medication). * Severe co-morbidity; diabetes mellitus type 1 (DM1), Mb Crohn or Colitis ulcerosa, systemic lupus erythematosus (SLE), HIV, Hepatitis B/C, or dysregulated thyroid disease. * ≥2 previous ART treatment without blastocyst formation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06358547 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 41 Years, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06358547 currently recruiting?
Yes, NCT06358547 is actively recruiting participants. Contact the research team at anja.bisgaard.pinborg@regionh.dk for enrollment information.
Where is the NCT06358547 trial being conducted?
This trial is being conducted at København Ø, Denmark.
Who is sponsoring the NCT06358547 clinical trial?
NCT06358547 is sponsored by Rigshospitalet, Denmark. The trial plans to enroll 590 participants.