Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06358547

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PGT-A

Diagnostic Test

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 outcomes

  1. Live birth rate per first embryo transfer

    Time frame: Approximately 12 months after inclusion of the last patient

    To assess if PGT-A is superior to standard non-PGT-A treatment regarding the live birth rate per first embryo transfer (ET) (or no ET if only aneuploid embryo(s) in the PGT-A group) per randomized woman.

  2. Cumulative live birth rate after one complete ART treatment

    Time frame: Approximately 18 months after inclusion of the last patient

    To assess if PGT-A is non-inferior compared to standard treatment regarding the cumulative LBR after one complete ART treatment per randomized woman.

Study contacts

Contact information is provided by the study sponsor or research team.

Anja Bisgaard Pinborg, MD

CONTACT

[email protected]

+4535454071

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years - a Randomized Controlled Multicenter Trial

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Apr 10, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.