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

Rigshospitalet

Status: Enrolling

Conditions: Infertility

Treatments: Diagnostic Test: PGT-A

Study type: Interventional

Funder types: Other

Identifiers

NCT06358547

H-23072469

Details and patient eligibility

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.

Enrollment: 590 estimated patients

Sex: Female

Ages: 18 to 41 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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590 participants in 2 patient groups

PGT-A

Experimental group

Description:

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.

Treatment:

Diagnostic Test: PGT-A

Control

No Intervention group

Description:

Non-PGT-A and fresh blastocyst transfer. In the non-PGT-A group, fresh day 5 single blastocyst transfer and/or FET of day 6 and/or day 7 blastocysts is used. LPS will be administered according to the participating clinics standard practice. All surplus day 5, day 6, or day 7 blastocysts will be vitrified. If there is a risk of OHSS, elective freeze-all will be performed. None of the blastocysts will be PGT-A tested.