Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years - a Randomized Controlled Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 590
- 试验地点
- 1
- 主要终点
- Cumulative live birth rate after one complete ART treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: PGT-A (Diagnostic Test)
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.
结局指标
主要结局
Cumulative live birth rate after one complete ART treatment
时间窗: Approximately 18 months after inclusion of the last patient
To assess if PGT-A is non-inferior compared to standard treatment regarding the cumulative LBR after one complete ART treatment per randomized woman.
Live birth rate per first embryo transfer
时间窗: Approximately 12 months after inclusion of the last patient
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.
次要结局
未报告次要终点
研究者
Anja Bisgaard Pinborg
Professor & medical director at the Fertility Clinic
Rigshospitalet, Denmark