2026-526292-37-01招募中4 期
Phase IV randomized, single-blind clinical trial with three parallel arms to compare ovulation triggering strategies in IVF cycles with fresh embryo transfer.
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2026年8月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Number of metaphase II (MII) oocytes retrieved at oocyte pickup.
研究概览
简要总结
To evaluate whether the addition of follitropin δ to hCG ovulation triggering increases the number of mature (MII) oocytes in women with low ovarian reserve undergoing fresh embryo transfer IVF cycles.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Women aged 18 to 42 years old.
- •Primary infertility.
- •Women with poor ovarian response who meet any of the groups defined by the POSEIDON criteria.
排除标准
- •More than two failed ovarian stimulation cycles.
- •Severe male factor (total motile sperm count [TMSC] <1 million).
- •Female age >42 years.
- •Criteria for extremely low ovarian reserve meeting Spanish National Health System (SNS) exclusion criteria (AMH <0.3 ng/mL and/or AFC <5).
- •Previous healthy child shared by the couple.
- •Presence of medical conditions contraindicating pregnancy.
- •Risk of ovarian hyperstimulation syndrome (OHSS). If more than 15 follicles are anticipated on the day of oocyte retrieval, the patient will be excluded from the study.
- •Previous voluntary sterilization (bilateral tubal ligation in the woman / vasectomy in the male partner).
- •Male partner age >55 years.
研究组 & 干预措施
Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable
Test
干预措施: Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable (Drug)
Ovitrelle 250 micrograms solution for injection in pre-filled pen, Ovitrelle 250 micrograms solution for injection in pre-filled pen, Ovitrelle 250 micrograms solution for injection in pre-filled pen, Ovitrelle 250 micrograms solution for injection in pre-filled pen
Test
干预措施: Ovitrelle 250 micrograms solution for injection in pre-filled pen (Drug)
Meriofert Kit 900 UI polvo y disolvente para solución inyectable
Auxiliary
干预措施: Meriofert Kit 900 UI polvo y disolvente para solución inyectable (Drug)
REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen, REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen, REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen, REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen
Test
干预措施: REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen (Drug)
REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen, REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen, REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen, REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen
Test
干预措施: REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen (Drug)
Orgalutran 0.25 mg/0.5 mL solution for injection, Orgalutran 0.25 mg/0.5 mL solution for injection, Orgalutran 0.25 mg/0.5 mL solution for injection, Orgalutran 0.25 mg/0.5 mL solution for injection
Auxiliary
干预措施: Orgalutran 0.25 mg/0.5 mL solution for injection (Drug)
结局指标
主要结局
Number of metaphase II (MII) oocytes retrieved at oocyte pickup.
Number of metaphase II (MII) oocytes retrieved at oocyte pickup.
次要结局
- Biochemical pregnancy rate and ongoing pregnancy rate.
- Gene expression of receptors and enzymes involved in folliculogenesis and ovarian steroidogenesis in mature oocytes.
- Proportion of mature oocytes (MII/total oocytes).
研究者
UICEC
Scientific
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
研究点 (1)
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