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临床试验/NCT05756023
NCT05756023招募中不适用

IVF\ICSI Outcome in Women With Polycystic Ovary Syndrome Compared With Non Polycystic Ovary Syndrome Women

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
156
试验地点
1
主要终点
pregnancy rate

研究概览

简要总结

Polycystic ovarian syndrome (PCOS) occurs in 5% to 10% of all women of reproductive age and 50% of women who present with sub-fertility due to anovulatory infertility . Clear diagnostic criteria for this condition were identified at the consensus meeting of the European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine .

详细描述

Sub-fertile women with PCOS will usually benefit from conventional treatments, such as lifestyle changes, ovulation induction, or laparoscopic ovarian drilling, but some will ultimately need assisted reproductive techniques, either if they will need or if they wish, such as controlled ovarian hyperstimulation and IVF.

In these cases, controlled ovarian hyperstimulation is closely related to high drug costs, need for daily injections and frequent monitoring, whereas it sometimes results in an increased rate of cycle cancellations and potential life threatening complications due to ovarian hyperstimulation syndrome and in the retrieval of immature oocytes, leading to poor fertilization and lower cleavage, pregnancy, and live birth rates compared to the conventional IVF cycles ,although this has not been confirmed by other studies .

In addition, ovulation induction is associated with a high risk of multiple pregnancies due to multiple follicular development, so that it has to be individualized and closely monitored.

In-vitro fertilization (IVF) is a common therapeutic modality used in infertile women. IVF has different success rates in different subgroups of patients.

It is necessary to alter the common standard protocols to overcome the potential obstacles in some populations of patients and achieve the best results . Obesity with PCOS status of patient may decrease the fertilization rate and clinical pregnancy chance after IVF (probably by decreasing the oocyte count and increasing the gonadotropin resistance); however, the results of different studies are conflicting

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Oligo-ovulation or anovulation.
  • Clinical and/or biochemical hyper androgenesim.
  • Polycystic ovaries.

排除标准

  • Androgen-secreting tumors (ovarian or adrenal).
  • Adult-onset congenital adrenal hyperplasia.
  • Thyroid diseases.
  • Cushing's syndrome.
  • Diabetes Mellitus.
  • recurrent ICSI failure
  • endocrine, hematologic and autoimmune disorders
  • Non chromosomal and genetic abnormalities
  • Major uterine anomalies, bad surgical history, sever endometriosis, , hydrosalpinx, uterine fibroids

结局指标

主要结局

pregnancy rate

时间窗: From baseline to 15 days after the embryo transfere day.

To compare the pregnancy rate at IVF / ICSI cycles between women with PCOS and non PCOS women

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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