Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years
NCT ID: NCT06358547
Last Updated: 2024-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
590 participants
INTERVENTIONAL
2024-08-01
2029-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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PGT-A
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.
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.
Control
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
41 Years
FEMALE
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Anja Bisgaard Pinborg
Professor & medical director at the Fertility Clinic
Locations
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Rigshospitalet
København Ø, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-23072469
Identifier Type: -
Identifier Source: org_study_id
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