Genetic testing for embryo quality in women aged 37-41

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of preimplantation genetic testing for aneuploidy (PGT-A) in women aged 37 to 41 years who are undergoing fertility treatments. Conducted across multiple fertility clinics in Denmark and Spain, the study aims to determine if PGT-A can improve pregnancy outcomes in this age group. Participants will be randomly assigned to receive either standard care or the PGT-A intervention during their IVF/ICSI cycles. The trial will assess the impact of genetic testing on embryo selection and overall fertility success rates.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rigshospitalet
  København Ø, Denmark Recruiting

Study contacts

• Study coordinator: Anja Bisgaard Pinborg, MD
• Email: anja.bisgaard.pinborg@regionh.dk
• Phone: +4535454071

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.