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临床试验/NCT03621683
NCT03621683已完成不适用

Antioxidants vs.Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve

Lucy Coleman2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2016年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
2
主要终点
variation of hormones FSH and LH directly involved with ovarian reserve

研究概览

简要总结

Two group of patients were selected. Group 1 represents 46 patients that received ovarian-biostimulation monthly for three months. Group 2 represents 32 patients that received antioxidant therapy daily for 3 months. Results are noted and analysed.

Both groups represent patients with procedures already ongoing, and with diagnosed poor or depleted ovarian reserve.

The analysis has been made to compare the efficacy of both procedures.

详细描述

The bioestimulation group received a blood rich platelet therapy monthly for three months, with a technique developed by the laboratory. The second group of antioxidants received a combination of antioxidants monthly for three months. Both groups were compared to assess the results in terms of ovarian response (number of astral follicles, AMH levels, FSH, LH), and egg quality, embryo development, implantation rate, and successful pregnancy with healthy live birth.

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
38 Years 至 46 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 38 and 46 years
  • FSH> 12 mIU
  • Estradiol > 100 pg/ml
  • AMH < 0.8 ng/mL

排除标准

  • Pelvic inflammatory syndrome
  • vaginal pathologies
  • known history of hyperandrogenism
  • diagnosed platelet disorders as adhesion
  • aggregation
  • disorder of thromboxane synthesis.

结局指标

主要结局

variation of hormones FSH and LH directly involved with ovarian reserve

时间窗: 18 months

Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with FSH-LH post-treatment.

variation of AMH directly involved with ovarian reserve in both groups

时间窗: 18 months

Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with AMH values.

variation in recruitment of antral follicles in both groups

时间窗: 18 months

Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with the number of astral follicles available.

次要结局

  • Number of good quality eggs obtained in both groups after IVF(18 months)
  • Number and quality of fertilised eggs obtained in both groups after IVF(18 months)

研究者

发起方
Lucy Coleman
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Lucy Coleman

Scientific director

Fertiaguerrevere

研究点 (2)

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