Agonist Trigger Versus Classical HCG Trigger in Controlled Ovarian Stimulation Among Three Different Subsets of Patients (Poor Responders, Normoresponders and High Responders)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mature oocytes
研究概览
简要总结
Agonist triggering in controlled ovarian stimulation protocols is being used during last years (among high responder patients to avoid OHSS).
Indeed, agonist triggering is more physiologic than HCG triggering. Investigators propose to compare the effectiveness of both types of trigger among three different subsets of patients:
- Poor responders.
- Normo-responders
- High responders Comparing both the number and the quality of achieved oocytes.
详细描述
During the last years, ovulation triggering in controlled ovarian stimulation protocols has been used specially to avoid hyperstimulation syndromes (OHSS). Indeed, the substitution of the classical HCG triggering by the agonist one, reduces almost to zero the risk of OHSS.
On the other hand poor responder patients to ovarian stimulation represent a challenge in assisted reproduction. Defining poor responders is not easy, but we can define them as those patients with less than 4 eggs obtained after oocyte retrieval.
Different strategies have been proposed to overcome this problem. In other words, to obtain more oocytes. These include an increase in FSH doses, an increase in FSH action by adding sensitizers agents.
Among the possible strategies, investigators propose the agonist triggering. HCG (classical) triggering represents the use of a LH-like product (with a prolonged action). The administration of a GnRH agonist provoke the production and liberation of both FSH and LH. Thus, the pro-ovulatory action is more physiologic , and possibly, more effective.
So, the use of a triggering protocol that nowadays is being used among high responders (thus reducing the OHSS risk) is proposed for both poor responder and normo-responder patients trying to achieve more oocytes, and specifically more mature oocytes.
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
- 18 Years 至 48 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women scheduled for IVF treatment.
- •First ovarian stimulation
- •Two ovaries present
- •No previous ovarian surgery
- •No contraindication for any of the assigned treatments
排除标准
- •Previous ovarian surgery.
- •Previous IVF treatments.
- •Absence of one ovary
- •Presence of an endometrioma
研究组 & 干预措施
Poor responders. Classical trigger
Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.
Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment.
干预措施: Human chorionic gonadotropin (Drug)
Poor responders. Agonist trigger
Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)
Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment.
干预措施: Gonadotropin Releasing Hormone Agonists (GNRH-A) (Drug)
Normo responders. Classical trigger
Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.
Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment.
干预措施: Human chorionic gonadotropin (Drug)
Normo responders. Agonist trigger
Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)
Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment.
干预措施: Gonadotropin Releasing Hormone Agonists (GNRH-A) (Drug)
High responders. Classical trigger
Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.
Women scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment.
干预措施: Human chorionic gonadotropin (Drug)
High responders. Agonist trigger
Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)
Women scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment.
干预措施: Gonadotropin Releasing Hormone Agonists (GNRH-A) (Drug)
结局指标
主要结局
Mature oocytes
时间窗: Up to 24 weeks
Number of mature oocytes achieved after oocyte retrieval.
次要结局
- Fertilized oocytes(Up to 24 weeks)
- Relation fertilized oocytes/achieved Mature oocytes(Up to 24 weeks)
- Relation mature oocytes/punctured oocytes(Up to 24 weeks)
- Number of blastocysts developed(Up to 24 weeks)
- Cancelled cycles(Up to 24 weeks)
研究者
Gorka Barrenetxea
Professor of Gynecology & Obstetrics Universidad del País Vasco/Euskal Herriko Unibertsitatea. Medical Director of Reproducción Bilbao
Ginegorama S.L.
