New treatment option for Infertility
Official title Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years
ClinicalTrials.gov ID: NCT06358547
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 41, women only
You may be able to join if
- 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®...
- 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 likely can't join 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...
See the full eligibility 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...
- IVF/ICSI cycle number 1-5 (previous IVF/ICSI cycles will not count if the woman is recruited after an IVF/ICSI/FET-delivery).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- København Ø, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 41 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include København Ø, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.