Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years

Recruiting now · Not applicable

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT06358547

Run by

Rigshospitalet, Denmark

People needed

590

Starts

2024-08-01

Expected to finish

2029-04-01

Last updated by the study team

2024-08-29

Who can join

Age: 18 and older, up to 41. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Rigshospitalet — København Ø, Denmark (enrolling)

Full record on ClinicalTrials.gov

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