An Uncontrolled, Open-label Feasibility Study to Demonstrate That a GnRH Agonist (Decapeptyl) Can be Safely Administered to Trigger Final Oocyte Maturation in High Responder Patients to Mitigate the Risk of OHSS
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety: The adverse event is the development of OHSS following oocyte retrieval.
研究概览
简要总结
Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.
详细描述
Administration of hCG (10.000 or 5.000 IU) is essential in IVF protocols to trigger final oocyte maturation after ovarian stimulation. In high responder patients with potential risk of developing OHSS, hCG is usually withheld and the treatment cycle is cancelled without obtaining (cryopreserved) embryos for replacement.
An alternative approach to trigger final oocyte maturation is to administer a GnRH agonist instead of hCG. This method is not possible following a long GnRH agonist protocol which causes down-regulation of the GnRH receptor. However, following GnRH antagonist treatment the GnRH receptor remains receptive to competitive binding by a GnRH agonist.
It has been well-described in earlier IVF trials that a bolus of GnRH agonist will displace the GnRH antagonist from the GnRH receptors in the pituitary inducing an endogenous LH (and FSH) surge resulting in the maturation of oocytes and good quality embryos. In addition, the risk of moderate-to-severe ovarian hyperstimulation syndrome (OHSS) becomes minimal due to the rapid demise of the corpora lutea. Following luteolysis, fresh embryo transfer would require alternative luteal phase support to secure good clinical outcome. Alternatively, good quality embryos obtained after GnRH agonist triggering can be cryopreserved and replaced in following frozen-thawn embryo transfer (FTET) cycles. Thus, also eliminating late onset OHSS due to pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A female patient who needs IVF to become pregnant.
- •Regular menstrual cycle.
- •Antral follicular count (AFC) > 18
- •Following treatment with follitropin beta more than 18 follicles ≥ 11 mm will develop.
排除标准
- •Hypersensitivity to the active substance or to any of the medications used.
- •Tumors of the ovary, breast, uterus, pituitary or hypothalamus.
- •Pregnancy.
- •Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
- •Primary ovarian failure.
- •Ovarian cysts or enlarged ovaries.
- •A history of Ovarian Hyperstimulation Syndrome (OHSS).
- •A previous COS cycle that resulted in more than 30 follicles > 11 mm measured by ultrasound examination.
- •Fibroid tumours of the uterus incompatible with pregnancy.
- •Malformations of the reproductive organs incompatible with pregnancy
研究组 & 干预措施
OHSS high risk patients
Triptorelin 0.2 mg
干预措施: Triptorelin 0.2 mg (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety: The adverse event is the development of OHSS following oocyte retrieval.
时间窗: 12 day from GnRH agonist trigger day.
OHSS usually occurs a few days following oocyte retrieval, and is not a threat once menses start.
次要结局
- Ongoing pregnancies following FTET cycles of cryopreserved embryos obtained following one treatment cycle of follitropin beta.(One month from embryo transfer date)
研究者
Dr. Shahar Kol
Principal Investigator
Elisha Hospital