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临床试验/NCT03139474
NCT03139474Unknown2 期

Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality in Intracytoplasmic Sperm Injection Cycles.

Assiut University0 个研究点目标入组 120 人开始时间: 2017年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
120
主要终点
number of maturated oocyte and good quality embryoes

研究概览

简要总结

The first In-Vitro Fertilization cycles were performed in natural unstimulated cycles. Today gonadotrophins are administered to induce multiple follicular development and controlled ovarian hyperstimulation. During ovarian stimulation gonadotrophin-releasing hormone analogues are co-administered in order to prevent premature luteinizing hormone surges. Premature luteinizing hormone surges are observed in about 20% of stimulated cycles without using gonadotrophin-releasing hormone analogues .

Avoiding the adverse effects of elevated luteinizing hormone levels, first gonadotrophin-releasing hormone agonist analogues were used to supplement the gonadotrophin stimulation. The continuous administration of gonadotrophin-releasing hormone agonists causes gonadotrophin suppression through down-regulation and desensitization of the gonadotrophin-releasing hormone receptors in the pituitary gland after an initial short period of gonadotrophin hypersecretion .

Gonadotrophin-releasing hormone antagonists (cetrorelix and ganirelix) cause immediate and rapid gonadotrophin suppression by competitive antagonism of the gonadotrophin-releasing hormone receptor in the pituitary without an initial period of gonadotrophin hypersecretion. Several advantageous effects of cetrorelix were established , and these effects seemed to be independent from the type of antagonist used for luteinizing hormone-suppression.The quality of oocytes and developing preembryos is one of the most relevant factors determining the success of an In-Vitro Fertilization treatment. As ovarian stimulation protocol is one of the eligible factors during an In-Vitro Fertilization treatment, its embryo quality influencing effects are necessary to know.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Unexplained infertility.
  • Tubal factor. Included treated hydrosalpinx and pyosalpinx
  • first cycle .
  • Body mass index: 18-
  • Follicle stimulating hormone not more than 14 , E2 not more than 80 and Antimullerian hormone >
  • Antral follicular count: more than 5 follicles in one ovary.
  • combined factors .
  • Normal male semen analysis: Mild male factor: concentrations 10 million - 20 million sperm/ml. Moderate male factor : concentrations 5 million - 10 million sperm/ml.

排除标准

  • Patients with Endometriosis.
  • Azoospermic male.
  • Body mass index more than 29.

研究组 & 干预措施

agonist group

Active Comparator

Triptorelin at a dose 1 milligram per day from the midluteal phase of the cycle preceding the treatment cycle to day 2 of the cycle then 0.5 milligram of triptorelin will be used during the period of stimulation.

干预措施: Gonadotropin-Releasing Hormone Analogue (Drug)

antagonist group

Active Comparator

•Multiple dose Gonadotrophin releasing hormone antagonist regimen will be used for ovarian stimulation 0.25 microgram per day cetrorelix will be administered from the 6th day of ovarian stimulation or from the presence of follicle 14 millimeter diameter .

干预措施: Gonadotropin releasing hormone antagonist (Drug)

结局指标

主要结局

number of maturated oocyte and good quality embryoes

时间窗: 14 days

次要结局

  • clinical pregnancy outcome(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Traiza Helal

Dr.

Assiut University

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