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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358547
• Other study ID #: H-23072469
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2029

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: Anja Bisgaard Pinborg, MD
• Phone: +4535454071
• Email: anja.bisgaard.pinborg[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 590
• Est. completion date: April 1, 2029
• Est. primary completion date: April 1, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 41 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneuploidy
• Infertility

Intervention

Diagnostic Test:
• PGT-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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	København Ø

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate per first embryo transfer	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.	Approximately 12 months after inclusion of the last patient
Primary	Cumulative live birth rate after one complete ART treatment	To assess if PGT-A is non-inferior compared to standard treatment regarding the cumulative LBR after one complete ART treatment per randomized woman.	Approximately 18 months after inclusion of the last patient