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临床试验/NCT05555680
NCT05555680终止不适用

Effect of Hyperandrogenism on IVF Success Rates in PCOS Patients

Clinique Ovo1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
32
试验地点
1
主要终点
Evaluate the effect of hyperandrogenism on frozen embryo transfer

研究概览

简要总结

Ovulatory dysfunction affects 18 to 25% of infertile women, the most common identifiable condition is polycystic ovarian syndrome (PCOS). The most frequent symptoms of PCOS are oligo-anovulation, hyperandrogenism and polycystic ovary appearance.

Hyperandrogenism is the main contributor that affects oocyte and embryo quality and decreases the success rates in PCOS patients undergoing IVF treatments.

The aim of this study is to determine the effect of hyperandrogenism as an independent factor on IVF success rates and oocyte/embryo quality in PCOS patients undergoing IVF.

详细描述

Despite that PCOS patients obtain a higher yield of oocytes retrieved in IVF treatments, they often have lower fertilization, cleavage and implantation rates and a higher rate of miscarriage, which can be attributed to a poor quality of retrieved oocytes and the resulting embryos. Multiple studies compared IVF outcomes in PCOS patients to control groups and found that PCOS might negatively affect oocyte maturation rate, fertilization rate in conventional IVF and miscarriage rate. Hence, it seems that PCOS might be associated with poor outcomes in IVF cycles when compared to non-PCOS patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between ages of 18 - 39 inclusively
  • ≥15 oocytes collected on the day of oocyte retrieval and/or anti-mullerian hormone (AMH) ≥ 4.0 ng/ml in the participant's medical chart in the last 24 months

排除标准

  • Male factor necessitating testicular sperm aspiration (TESA), testicular sperm extraction (TESE) or micro-TESE
  • Fertility preservation
  • Recurrent pregnancy losses (RPL) (defined as 2 or more failed clinical pregnancies as documented by ultrasonography or histopathologic examination,or 3 or more failed pregnancies before 14 weeks of gestation)
  • Oocyte donation
  • Medical diagnosis of non classic congenital adrenal hyperplasia diagnosed based on 17 hydroxyprogesterone level

结局指标

主要结局

Evaluate the effect of hyperandrogenism on frozen embryo transfer

时间窗: 10 days after frozen embryo transfer

Determine the effect of PCOS subjects affected by hyperandrogenism (HA) on clinical pregnancy rate following a frozen embryo transfer

次要结局

未报告次要终点

研究者

发起方
Clinique Ovo
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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