NCT07691073尚未招募4 期
The Impact of Ovarian Stimulation With hMG on Embryo Quality in Advanced Age Women. A Randomized Controlled Trial
Fundacion Dexeus4 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2026年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Good quality blastocysts
研究概览
简要总结
Ovarian stimulation (OS) is a key component of IVF, aimed at increasing oocyte yield and improving embryo development potential. While early protocols relied solely on FSH, newer approaches incorporate hMG and LH-based stimulation, allowing more individualized treatments for specific patient populations. Evidence suggests that hMG and recombinant FSH (rFSH) have comparable effectiveness in stimulation outcomes, and current guidelines support the use of both. However, the impact of different gonadotropins on embryo quality remains unclear, with mixed findings across protocols. Given the increasing use of combined rFSH and hMG and the limited data in PPOS protocols, this study proposes a randomized controlled trial to compare embryo quality between two different rFSH-hMG dosing strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 38 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergoing preimplantation genetic screening cycles
- •AMH 0.5 - 3.5 ng/ml or AFC 5-20 (results of up to one year will be valid)
- •BMI 18.5 - 30 Kg/m2
- •Normal karyotypes in both partners
排除标准
- •Previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol), according to Bologna criteria
- •Severe male factor requiring TESE (testicular sperm extraction)
- •Administration of any other drug potentially interfering with the treatment
- •Contraindication for hormonal treatment
- •Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfere with the trial assessment)
- •Monogenic disease to be detected with PGT-M
- •Biochemical and/or ultrasonographic evidence of polycystic ovarian syndrome
- •Endocrinological and/or autoimmune disorders
结局指标
主要结局
Good quality blastocysts
时间窗: From Day 5 to Day 7 after insemination
number of good quality blastocysts based on the Istanbul consensus workshop criteria
次要结局
- Total Gonadotropin Dose Administered(From initiation of ovarian stimulation until day of trigger (up to 15 days))
- Duration of Ovarian Stimulation(From first day of stimulation until trigger day (up to 15days))
- Total Number of Oocytes Retrieved(At oocyte retrieval)
- Number of mature oocytes (MII) retrieved(At oocyte retrieval)
- Serum levels of estradiol (E2)(At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days))
- Serum levels of progesterone (P4)(At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days))
- Serum levels of follicle-stimulating hormone (FSH)(At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days))
- Serum levels of luteinizing hormone (LH)(At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days))
- Follicle-to-Oocyte Index (FOI)(From baseline AFC assessment to oocyte retrieval)
- Follicular Output RaTe (FORT)(From baseline AFC assessment to trigger day)
- Cycle cancellation rate(From start of stimulation to planned oocyte retrieval)
- Reason for cycle cancellation(At time of cycle cancellation)
- Fertilization Rate(Assessed 16-20 hours post-insemination or ICSI)
- Time of appearance of the 2nd polar body (tPB2)(Within 0-6 hours post-ICSI/insemination)
- Time of pronuclei appearance (tPNa)(Within 0-20 hours post-ICSI/insemination)
- Evaluation of both pronuclei(Within 0-20 hours post-ICSI/insemination)
- Time to Pronuclear Fading (tPNf)(Within 20-30 hours post-ICSI/insemination)
- Timing of Early Cleavage Stages (t2-t8)(From fertilization to Day 3 (up to 72 hours))
- Time of compaction (tSC)(Day 3-4 post-fertilization (up to ~96 hours))
- Time of morula (tM)(Day 4 post-fertilization (up to 120 hours))
- Time of cavitation (tSB)(Day 4-5 post-fertilization (up to ~120-132 hours))
- Time of full blastulation (tB)(Day 5-6 post-fertilization (up to ~144 hours))
- Total number of Day 5 blastocysts(Day 5 post-fertilization)
- Total number of Day 6 blastocysts(Day 5 post-fertilization)
- Total number of Day 7 blastocysts(Day 5 post-fertilization)
- Total number of euploid embryos(After genetic testing results (typically within 1-2 weeks post-biopsy))
- MII to blastocyst formation rate(From oocyte retrieval to blastocyst stage (up to Day 5-7))
- Number of embryos cryopreserved(At end of embryo culture (Day 5-7))
- Clinical pregnancy rate(At 5-7 weeks of gestation)
- Ongoing Pregnancy Rate(At 8-10 weeks of gestation)
- Miscarriage Rate(From confirmation of clinical pregnancy up to 20 weeks of gestation)
- Live birth rate(At delivery (up to ~40 weeks of gestation following embryo transfer))
研究者
研究点 (4)
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