跳至主要内容
临床试验/NCT03307720
NCT03307720Unknown不适用

Agonist Trigger Versus Classical HCG Trigger in Controlled Ovarian Stimulation Among Three Different Subsets of Patients (Poor Responders, Normoresponders and High Responders)

Ginegorama S.L.1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年12月18日最近更新:
适应症
干预措施
相关药物

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:

  1. Poor responders.
  2. Normo-responders
  3. 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

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

Active Comparator

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

Experimental

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

Active Comparator

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

Experimental

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

Active Comparator

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

Experimental

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

发起方
Ginegorama S.L.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gorka Barrenetxea

Professor of Gynecology & Obstetrics Universidad del País Vasco/Euskal Herriko Unibertsitatea. Medical Director of Reproducción Bilbao

Ginegorama S.L.

研究点 (1)

Loading locations...

相似试验