Genetic testing for embryo quality in women aged 37-41
Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years - a Randomized Controlled Multicenter Trial
This study is testing if a genetic test for embryo quality can help women aged 37 to 41 who are trying to get pregnant through fertility treatments have better chances of a successful pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 590 (estimated) |
| Ages | 18 Years to 41 Years |
| Sex | Female |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (København Ø) |
| Trial ID | NCT06358547 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of preimplantation genetic testing for aneuploidy (PGT-A) in women aged 37 to 41 years who are undergoing fertility treatments. Conducted across multiple fertility clinics in Denmark and Spain, the study aims to determine if PGT-A can improve pregnancy outcomes in this age group. Participants will be randomly assigned to receive either standard care or the PGT-A intervention during their IVF/ICSI cycles. The trial will assess the impact of genetic testing on embryo selection and overall fertility success rates.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 37-41 years with a male partner or those undergoing fertility treatment without a partner, who meet specific hormonal criteria.
Not a fit: Patients with severe endometriosis, significant thyroid disease, or those requiring specific sperm retrieval techniques may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the chances of successful pregnancies for women in this age group facing infertility.
How similar studies have performed: Previous studies have shown promising results with preimplantation genetic testing, indicating potential benefits in improving embryo selection and pregnancy outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
København Ø
- Rigshospitalet — København Ø, Denmark (Recruiting)
Study contacts
- Study coordinator: Anja Bisgaard Pinborg, MD
- Email: anja.bisgaard.pinborg@regionh.dk
- Phone: +4535454071
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.