Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PGT-A.
- Who it may be relevant to
- Registry conditions: Infertility. Basic parameters: 18 years — 41 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years - a Randomized Controlled Multicenter Trial
Overview
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.
Interventions
- Diagnostic test PGT-A
PGT-A is a technique that allows for the prediction of embryo ploidy status through analysis of a trophectoderm biopsy conducted prior to embryo transfer.
Primary outcome measures
- Live birth rate per first embryo transfer [Time frame: Approximately 12 months after inclusion of the last patient]
- Cumulative live birth rate after one complete ART treatment [Time frame: Approximately 18 months after inclusion of the last patient]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Denmark · 1 center
- Rigshospitalet — København Ø
Identifiers
NCT: NCT06358547 · H-23072469