Infertility
Conditions
Brief summary
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_TESTPGT-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.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 41 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative live birth rate after one complete ART treatment | 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. |
| Live birth rate per first embryo transfer | 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. |
Countries
Denmark
Contacts
Primary ContactAnja Bisgaard Pinborg, MD
Outcome results
None listed