Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years
Not Applicable
Recruiting
- Conditions
- Infertility
- Interventions
- Diagnostic Test: PGT-A
- Registration Number
- NCT06358547
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 590
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PGT-A PGT-A PGT-A and freeze-all (by vitrification) of day 5 and/or day 6 and/or day 7 blastocyst(s) and subsequent transfer of euploid or mosaic (≤80%) blastocysts in FET cycles. Luteal phase supplementation (LPS) will be administered according to the participating clinics standard practice.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰København Ø, Denmark