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

NCT06358547 | Recruiting DMC

• 1 other identifier: H-23072469
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

PGT-A

EXPERIMENTAL

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.

Diagnostic Test: PGT-A

Control

NO INTERVENTION

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.

Interventions

PGT-A DIAGNOSTIC_TEST

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.

PGT-A

Eligibility Criteria

• Age: 18 Years - 41 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 37-41 years with a male partner, a female partner og undergoing fertility with no partner.
• IVF/ICSI cycle number 1-5 (previous IVF/ICSI cycles will not count if the woman is recruited after an IVF/ICSI/FET-delivery).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

København Ø, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Anja Bisgaard Pinborg, MD

CONTACT

+4535454071; anja.bisgaard.pinborg@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & medical director at the Fertility Clinic

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

DK (1)