Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years (NCT06358547) | Clinical Trial Compass
RecruitingNot Applicable
Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years
Denmark590 participantsStarted 2024-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 41 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Live birth rate per first embryo transfer
Timeframe: Approximately 12 months after inclusion of the last patient
2
Cumulative live birth rate after one complete ART treatment
Timeframe: Approximately 18 months after inclusion of the last patient