Actively Recruiting

Phase Not Applicable
Age: 18Years - 41Years
FEMALE
NCT06358547

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

Led by Rigshospitalet, Denmark · Updated on 2024-08-29

590

Participants Needed

1

Research Sites

243 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 41Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 37-41 years with a male partner, female partner, or undergoing fertility treatment without a partner
  • Anti Müllerian Hormone (AMH) level of 6.28 pmol/L or higher measured within one year before inclusion (preferably using the Elecsys® Assay)
  • IVF or ICSI cycle number between 1 and 5 (previous cycles after an IVF/ICSI/FET delivery do not count)
Not Eligible

You will not qualify if you...

  • Previous use of PGT-SR or PGT-M
  • Use of testicular sperm procedures like TESA, TESE, micro-TESE, or cryopreserved sperm from these
  • Male partner with severely compromised semen quality (fewer than 1 million progressively motile sperm after gradient centrifugation)
  • Endometriosis stage three or four
  • Severe thyroid disease (except if thyroid levels are normal with medication)
  • Severe co-morbidities such as type 1 diabetes, Crohn's disease, ulcerative colitis, systemic lupus erythematosus, HIV, hepatitis B or C, or uncontrolled thyroid disease
  • Two or more previous ART treatments without blastocyst formation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rigshospitalet

København Ø, Denmark, 2100

Actively Recruiting

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Research Team

A

Anja Bisgaard Pinborg, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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