Comparison of Embryo Transfer With and Without PGS for the Indication of Advanced Reproductive Age (37-42) in Patients Undergoing ART
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 1,200
- 试验地点
- 9
- 主要终点
- ongoing pregnancy rate (past 2nd trimester).
研究概览
简要总结
The objective of this study is to demonstrate that Preimplantation Genetic diagnosis will significantly reduce spontaneous abortions and increase ongoing pregnancy rates in patients of advanced maternal age (37-42) undergoing IVF. We would like to test this hypothesis by a randomized trial performed with the most suitable conditions using very successful IVF laboratories capable to perform the embryo biopsy under strict controlled conditions after proper training and validation of the techniques.
详细描述
Indications: Patients of advanced reproductive age wishing to receive preimplantation genetic screening in ART.
Objectives: To demonstrate that Preimplantation Genetic diagnosis (PGD) will significantly reduce spontaneous abortions and increase ongoing pregnancy rates in patients of advanced maternal age (37-42) undergoing IVF.
Test Method: Preimplantation Genetic Screening through FISH Treatment: In Vitro Fertilization treatment. The resulting embryos of the test group will undergo embryo biopsy followed by PGD with FISH using a 10-probe test with "no result rescue".
Study Population: 978 infertile women undergoing ART Major Inclusions: Premenopausal infertile women wishing to conceive, aged 37 42 years, inclusive, regular menstrual cycles and screening early follicular phase FSH within normal limits.
Major Exclusions: Clinically significant systemic disease; any contraindication to pregnancy or carrying pregnancy to term; known ASRM Grade III or IV endometriosis; clinically significant abnormal findings on a transvaginal ultrasound within 6 weeks prior to the beginning of OCP treatment; extrauterine pregnancy within 3 months prior to the beginning of OCP treatment; poor response in a previous ART cycle (≤ 3 oocytes retrieved); ≥ 3 prior, initiated, consecutive ART cycles without a clinical pregnancy; prior severe OHSS; TESA and TESE patients; patients carriers of chromosomal or genetic diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 37 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal infertile women wishing to conceive
- •Aged 37 42 years, inclusive,
- •Regular menstrual cycles (generally 25 35 days in length) and screening early follicular phase FSH within normal limits.
排除标准
- •Clinically significant systemic disease;
- •Any contraindication to pregnancy or carrying pregnancy to term;
- •Known ASRM Grade III or IV endometriosis;
- •Clinically significant abnormal findings on a transvaginal ultrasound within 6 weeks prior to the beginning of OCP treatment;
- •Extrauterine pregnancy within 3 months prior to the beginning of OCP treatment;
- •≥ 3 prior, initiated, consecutive ART cycles without a clinical pregnancy;
- •Prior severe OHSS;
- •TESA and TESE patients;
- •Patients carriers of chromosomal or genetic diseases.
- •Egg donation cycles.
- •Frozen Cycles.
结局指标
主要结局
ongoing pregnancy rate (past 2nd trimester).
时间窗: after 21 days, 20 weeks, and 7 month of treatment
次要结局
- spontaneous abortions(within 1st and 2nd trimester)
- implantation(first month, for presence of fetal sacs)
- pregnancy(one month for presence of fetal sac)